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Staying Active With Arthritis: RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280903
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Elizabeth Schlenk, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoarthritis, Knee
Hypertension
Interventions Behavioral: STAR Intervention
Behavioral: Attention-Control
Enrollment 182
Recruitment Details  
Pre-assignment Details  
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Period Title: Overall Study
Started 91 91
Completed 68 [1] 75 [1]
Not Completed 23 16
Reason Not Completed
Lost to Follow-up             23             16
[1]
91 participants analyzed per intention-to-treat
Arm/Group Title STAR Intervention Attention-Control Total
Hide Arm/Group Description

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Total of all reporting groups
Overall Number of Baseline Participants 91 91 182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 91 participants 182 participants
64.47  (8.46) 64.96  (7.76) 64.71  (8.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 91 participants 182 participants
Female
67
  73.6%
66
  72.5%
133
  73.1%
Male
24
  26.4%
25
  27.5%
49
  26.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 91 participants 182 participants
Hispanic or Latino
3
   3.3%
3
   3.3%
6
   3.3%
Not Hispanic or Latino
88
  96.7%
88
  96.7%
176
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 91 participants 182 participants
American Indian or Alaska Native
1
   1.1%
0
   0.0%
1
   0.5%
Asian
2
   2.2%
1
   1.1%
3
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  18.7%
15
  16.5%
32
  17.6%
White
66
  72.5%
66
  72.5%
132
  72.5%
More than one race
5
   5.5%
9
   9.9%
14
   7.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 91 participants 91 participants 182 participants
91 91 182
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 91 participants 91 participants 182 participants
34.50  (7.48) 33.64  (6.43) 34.07  (6.97)
Number of comorbidities  
Mean (Standard Deviation)
Unit of measure:  Comorbidities
Number Analyzed 91 participants 91 participants 182 participants
6.8  (2.9) 6.5  (2.7) 6.6  (2.8)
Marital status  
Measure Type: Number
Unit of measure:  Participants
Married Number Analyzed 91 participants 91 participants 182 participants
38 46 84
Not married Number Analyzed 91 participants 91 participants 182 participants
53 45 98
Educational status  
Measure Type: Number
Unit of measure:  Participants
> High school Number Analyzed 91 participants 91 participants 182 participants
72 71 143
High school or less Number Analyzed 91 participants 91 participants 182 participants
19 19 39
Missing Number Analyzed 91 participants 91 participants 182 participants
0 1 0
Employment status  
Measure Type: Number
Unit of measure:  Participants
Employed Number Analyzed 91 participants 91 participants 182 participants
45 43 88
Not employed Number Analyzed 91 participants 91 participants 182 participants
46 48 94
Household income  
Measure Type: Number
Unit of measure:  Participants
< $50,000/year Number Analyzed 91 participants 91 participants 182 participants
37 38 75
$50,000 or more/year Number Analyzed 91 participants 91 participants 182 participants
39 38 77
Missing Number Analyzed 91 participants 91 participants 182 participants
15 15 30
Lower extremity exercise (e-diary): days/week  
Mean (Standard Deviation)
Unit of measure:  Days/week
Number Analyzed 91 participants 91 participants 182 participants
0.41  (1.01) 0.36  (1.02) 0.38  (1.01)
Lower extremity exercise (e-diary): minutes/week  
Mean (Standard Deviation)
Unit of measure:  Minutes/week
Number Analyzed 91 participants 91 participants 182 participants
7.60  (24.87) 7.43  (24.51) 7.52  (24.52)
Lower extremity exercise (e-diary): average minutes/day  
Mean (Standard Deviation)
Unit of measure:  Average minutes/day
Number Analyzed 91 participants 91 participants 182 participants
1.09  (3.55) 1.06  (3.47) 1.07  (3.50)
Lower extremity exercise (e-diary): volume [repetitions x sets over 7-day period]/week  
Mean (Standard Deviation)
Unit of measure:  Repetitions x sets/week
Number Analyzed 91 participants 91 participants 182 participants
56.93  (255.39) 30.41  (121.21) 43.67  (199.79)
Fitness walking (e-dairy): days/week  
Mean (Standard Deviation)
Unit of measure:  Days/week
Number Analyzed 91 participants 91 participants 182 participants
0.65  (1.41) 0.57  (1.31) 0.61  (1.36)
Fitness walking (e-diary): minutes/week  
Mean (Standard Deviation)
Unit of measure:  Minutes/week
Number Analyzed 91 participants 91 participants 182 participants
18.54  (47.45) 15.33  (37.83) 16.93  (42.82)
Fitness walking (e-diary): average minutes/day  
Mean (Standard Deviation)
Unit of measure:  Average minutes/day
Number Analyzed 91 participants 91 participants 182 participants
2.65  (6.78) 2.19  (5.40) 2.42  (6.12)
Activity minutes over 7 days (ActiGraph): no to very low (counts of 0-99/min)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 91 participants 91 participants 182 participants
3155.5  (714.6) 2934.8  (842.3) 3045.2  (786.7)
Activity minutes over 7 days (ActiGraph): light (counts of 100-2,019/min)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 91 participants 91 participants 182 participants
2348.7  (572.0) 2418.8  (632.1) 2383.8  (602.2)
Activity minutes over 7 days (ActiGraph): moderate-to-vigorous (counts of > 2,020/min)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 91 participants 91 participants 182 participants
275.8  (154.0) 365.5  (288.4) 320.6  (234.9)
Number of bouts over 7 days (ActiGraph): bouts of moderate-to-vigorous activity  
Mean (Standard Deviation)
Unit of measure:  Bouts
Number Analyzed 91 participants 91 participants 182 participants
1.7  (2.6) 2.7  (6.5) 2.2  (5.0)
Mean duration of bouts over 7 days (ActiGraph): bouts of moderate-to-vigorous activity n=96   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 45 participants 51 participants 96 participants
17.2  (7.5) 19.9  (8.7) 18.6  (8.2)
[1]
Measure Analysis Population Description: Some participants in each group had no bouts at baseline of => 10 consecutive minutes participating in activity at the => 2,020 counts threshold.
Mean number of daily activity minutes (ActiGraph): no to very low (counts of 0-99/min)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 91 participants 91 participants 182 participants
440.14  (96.5) 410.26  (111.1) 425.2  (104.9)
Mean number of daily activity minutes (ActiGraph): light (counts of 100-2,019/min)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 91 participants 91 participants 182 participants
327.5  (76.8) 339.3  (86.4) 333.4  (81.7)
Mean number of daily activity minutes (ActiGraph): moderate-to-vigorous (counts of >2,020/min)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 91 participants 91 participants 182 participants
38.3  (20.7) 51.2  (38.7) 44.7  (31.6)
Mean number of daily bouts (ActiGraph): bouts of moderate-to-vigorous activity  
Mean (Standard Deviation)
Unit of measure:  Bouts
Number Analyzed 91 participants 91 participants 182 participants
0.2  (0.4) 0.4  (0.9) 0.3  (0.7)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 91 participants 91 participants 182 participants
122.09  (15.01) 121.82  (13.78) 121.96  (14.37)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 91 participants 91 participants 182 participants
72.86  (11.18) 73.15  (9.47) 73.01  (10.33)
6-minute walk  
Mean (Standard Deviation)
Unit of measure:  Yards
Number Analyzed 91 participants 91 participants 182 participants
486.2  (105.9) 484.7  (88.1) 485.5  (97.1)
Short Physical Performance Battery: total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
11.0  (1.7) 10.6  (1.6) 10.8  (1.6)
[1]
Measure Description: Subscale scores are summed for a total scale score; the total scale score range is 0-13; higher scores are better
Short Physical Performance Battery: repeated chair stands   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
2.9  (1.2) 2.7  (1.1) 2.8  (1.1)
[1]
Measure Description: The repeated chair stands subscale score range is 0-4; higher scores are better
Short Physical Performance Battery: 4-meter usual walk   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
4.0  (0.2) 4.0  (0.0) 4.0  (0.2)
[1]
Measure Description: The 4-meter usual walk subscale score range is 0-4; higher scores are better
Short Physical Performance Battery: standing balance   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
4.2  (0.8) 4.0  (0.9) 4.1  (0.8)
[1]
Measure Description: The standing balance subscale score range is 0-5; higher scores are better
Chair sit-and-reach  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 91 participants 91 participants 182 participants
-1.4  (5.7) -0.8  (5.6) -1.1  (5.6)
8-foot up-and-go  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 91 participants 91 participants 182 participants
6.5  (1.8) 6.6  (1.3) 6.6  (1.6)
Quadriceps strength (mean maximum for right and left quadriceps)  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 91 participants 91 participants 182 participants
41.8  (13.5) 43.0  (16.1) 42.4  (14.8)
Western Ontario and McMaster Universities Osteoarthritis Index: Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
5.8  (3.9) 4.8  (3.0) 5.3  (3.5)
[1]
Measure Description: The WOMAC Osteoarthritis Index Pain subscale score range is 0-20; lower scores are better
Western Ontario and McMaster Universities Osteoarthritis Index: Function   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
22.5  (13.4) 19.3  (11.9) 20.9  (12.8)
[1]
Measure Description: The WOMAC Osteoarthritis Index Function subscale score range is 0-68; lower scores are better
Western Ontario and McMaster Universities Osteoarthritis Index: Stiffness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
3.1  (1.8) 2.7  (1.8) 2.9  (1.8)
[1]
Measure Description: The WOMAC Osteoarthritis Index Stiffness subscale score range is 0-8; lower scores are better
Short Form-36v2 Health Survey: Bodily Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
55.7  (20.3) 56.8  (18.7) 56.2  (19.5)
[1]
Measure Description: The subscale score range is 0-100; higher scores are better
Short Form-36v2 Health Survey: Physical Functioning   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
62.0  (23.4) 65.2  (19.7) 63.6  (21.6)
[1]
Measure Description: The subscale score range is 0-100; higher scores are better
Short Form-36v2 Health Survey: Physical Component Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
42.0  (8.8) 42.8  (8.6) 42.4  (8.7)
[1]
Measure Description: This summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better
Short Form-36v2 Health Survey: Mental Component Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
53.4  (9.8) 54.0  (9.4) 53.7  (9.6)
[1]
Measure Description: This summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better
Brief Fatigue Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
2.8  (2.6) 2.7  (2.2) 2.8  (2.4)
[1]
Measure Description: The scale score range is 0-10; lower scores are better
Self-efficacy: Exercise   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
72.8  (28.0) 74.4  (27.2) 73.6  (27.5)
[1]
Measure Description: The subscale score range is 0-100; higher scores are better
Self-efficacy: Exercise Barriers   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
60.3  (25.6) 68.3  (21.4) 64.3  (23.9)
[1]
Measure Description: The subscale score range is 0-100; higher scores are better
Self-efficacy: Arthritis Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
73.7  (17.0) 74.4  (18.2) 74.1  (17.6)
[1]
Measure Description: The subscale score range is 10-100; higher scores are better
Self-efficacy: Arthritis Function   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
83.1  (15.5) 85.2  (15.6) 84.2  (15.6)
[1]
Measure Description: The subscale score range is 10-100; higher scores are better
Self-efficacy: Arthritis Other Symptoms   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
76.8  (17.4) 77.8  (17.2) 77.3  (17.2)
[1]
Measure Description: The subscale score range is 10-100; higher scores are better
Perceived Therapeutic Efficacy - Exercise & Arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
67.8  (24.5) 72.1  (21.7) 70.0  (23.1)
[1]
Measure Description: The PTE Exercise & Arthritis scale score range is 0-100; higher scores are better
Perceived Therapeutic Efficacy - Exercise & Hypertension   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 91 participants 182 participants
74.2  (21.2) 74.7  (23.4) 74.5  (22.3)
[1]
Measure Description: The PTE Exercise & Hypertension scale score range is 0-100; higher scores are better
1.Primary Outcome
Title Performance of Lower Extremity Exercise at 25 Weeks
Hide Description Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the participant reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period).
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: repetitions x sets/week
46.84  (4.59) 1.90  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Participation in Fitness Walking at 25 Weeks
Hide Description Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: minutes
None to very low 434.89  (11.69) 409.98  (11.54)
Light 314.07  (9.29) 321.44  (9.18)
Moderate-to-vigorous 40.53  (2.68) 46.69  (3.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments p=0.130 for None to very low
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.573
Comments p=0.573 for Light
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments p=0.197 for Moderate-to-vigorous
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Objective Functional Status by the 6-minute Walk at 25 Weeks
Hide Description Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: yards
465.46  (18.82) 483.02  (14.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.461
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Primary Outcome
Title Objective Functional Status by the Short Physical Performance Battery at 25 Weeks
Hide Description Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
11.29  (0.22) 10.86  (0.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Primary Outcome
Title Systolic Blood Pressure at 25 Weeks
Hide Description Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: mm Hg
120.33  (1.74) 123.07  (1.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Primary Outcome
Title Diastolic Blood Pressure at 25 Weeks
Hide Description Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: mm Hg
71.74  (1.20) 73.10  (1.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Primary Outcome
Title Performance of Lower Extremity Exercise at 52 Weeks
Hide Description Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the subject reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period).
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: repetitions x sets/week
42.06  (6.74) 3.14  (1.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
8.Primary Outcome
Title Participation in Fitness Walking at 52 Weeks
Hide Description Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: minutes
None to very low 426.71  (11.97) 408.30  (11.70)
Light 318.04  (9.50) 321.01  (9.30)
Moderate-to-vigorous 39.37  (2.74) 47.97  (3.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments p=0.272 for None to very low
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments p=0.823 for Light
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments p=0.076 for Moderate-to-vigorous
Method Mixed Models Analysis
Comments [Not Specified]
9.Primary Outcome
Title Objective Functional Status by the 6-minute Walk at 52 Weeks
Hide Description Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: yards
480.29  (16.89) 465.36  (19.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Primary Outcome
Title Objective Functional Status by the Short Physical Performance Battery at 52 Weeks
Hide Description Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
11.20  (0.24) 11.25  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.856
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
11.Primary Outcome
Title Systolic Blood Pressure at 52 Weeks
Hide Description Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: mm Hg
122.54  (1.78) 125.14  (1.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.292
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
12.Primary Outcome
Title Diastolic Blood Pressure at 52 Weeks
Hide Description Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: mm Hg
72.62  (1.22) 74.06  (1.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.396
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title Subjective Functional Status at 25 Weeks
Hide Description Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
16.68  (1.44) 18.30  (1.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Quadriceps Strength at 25 Weeks
Hide Description Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: pounds
43.21  (1.75) 41.88  (1.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
15.Secondary Outcome
Title Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks
Hide Description Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
4.25  (0.39) 4.54  (0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.596
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
16.Secondary Outcome
Title Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks
Hide Description Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
59.65  (2.32) 58.13  (2.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.639
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Fatigue at 25 Weeks
Hide Description Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.
Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
2.49  (0.27) 2.76  (0.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.466
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Health-Related Quality of Life at 25 Weeks
Hide Description

Measured by the Short Form-36v2 in terms of the following:

Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better

Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Short Form-36v2 Mental Component 53.92  (1.11) 52.30  (1.20)
Short Form-36v2 Physical Component 43.10  (0.97) 43.07  (0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments p=0.322 for Short Form-36v2 Mental Component
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments p=0.979 for Short Form-36v2 Physical Component
Method Mixed Models Analysis
Comments [Not Specified]
19.Secondary Outcome
Title Self-Efficacy at 25 Weeks
Hide Description

Measured by the Self-Efficacy Scale in terms of the following:

Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better

Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Exercise Barriers Self-Efficacy 59.81  (2.77) 58.37  (2.69)
Exercise Self-Efficacy 67.43  (3.44) 60.20  (3.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments p=0.710 for Exercise Barriers Self-Efficacy
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments p=0.133 for Exercise Self-Efficacy
Method Mixed Models Analysis
Comments [Not Specified]
20.Secondary Outcome
Title Arthritis Self-Efficacy at 25 Weeks
Hide Description

Measured by the Arthritis Self-Efficacy Scale in terms of the following:

Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better

Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Arthritis Self Efficacy Pain 75.58  (1.97) 67.38  (2.13)
Arthritis Self-Efficacy Function 85.74  (1.79) 85.90  (1.67)
Arthritis Self-Efficacy Other Symptoms 78.88  (1.99) 77.66  (1.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments p=0.005 for Arthritis Self Efficacy Pain
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments p=0.948 for Arthritis Self Efficacy Function
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.663
Comments p=0.663 for Arthritis Self Efficacy Other Symptoms
Method Mixed Models Analysis
Comments [Not Specified]
21.Secondary Outcome
Title Outcome Expectancy at 25 Weeks
Hide Description

Measured by the Perceived Therapeutic Efficacy Scale in terms of the following:

Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better

Time Frame At the end of the 6-month intervention period (week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Perceived Therapeutic Efficacy Arthritis 72.79  (2.41) 59.67  (2.91)
Perceived Therapeutic Efficacy Hypertension 77.14  (2.48) 69.62  (2.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension
Method Mixed Models Analysis
Comments [Not Specified]
22.Secondary Outcome
Title Subjective Functional Status at 52 Weeks
Hide Description Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
17.02  (1.49) 17.51  (1.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
23.Secondary Outcome
Title Quadriceps Strength at 52 Weeks
Hide Description Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: pounds
43.66  (1.77) 43.33  (1.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
24.Secondary Outcome
Title Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks
Hide Description Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
4.09  (0.41) 4.72  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
25.Secondary Outcome
Title Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks
Hide Description Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
59.73  (2.36) 59.70  (2.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
26.Secondary Outcome
Title Fatigue at 52 Weeks
Hide Description Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.
Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
2.97  (0.28) 2.94  (0.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
27.Secondary Outcome
Title Health-Related Quality of Life at 52 Weeks
Hide Description

Measured by the Short Form-36v2 in terms of the following:

Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better

Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Short Form-36v2 Mental Component 53.18  (1.12) 51.81  (1.21)
Short Form-36v2 Physical Component 42.10  (1.18) 42.47  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments p=0.406 for Short Form-36v2 Mental Component
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments p=0.826 for Short Form-36v2 Physical Component
Method Mixed Models Analysis
Comments [Not Specified]
28.Secondary Outcome
Title Self-Efficacy at 52 Weeks
Hide Description

Measured by the Self-Efficacy Scale in terms of the following:

Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better

Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
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Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Exercise Barriers Self-Efficacy 53.30  (2.83) 53.05  (2.73)
Exercise Self-Efficacy 55.49  (3.56) 51.00  (3.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.950
Comments p=0.950 for Exercise Barriers Self-Efficacy
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments p=0.365 for Exercise Self-Efficacy
Method Mixed Models Analysis
Comments [Not Specified]
29.Secondary Outcome
Title Arthritis Self-Efficacy at 52 Weeks
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Measured by the Arthritis Self-Efficacy Scale in terms of the following:

Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better

Time Frame 6 months after the intervention period ends (week 52)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Arthritis Self-Efficacy Pain 73.15  (2.06) 69.44  (2.19)
Arthritis Self-Efficacy Function 85.38  (1.82) 87.75  (1.69)
Arthritis Self-Efficacy Other Symptoms 75.92  (2.03) 75.23  (1.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments p=0.219 for Arthritis Self Efficacy Pain
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments p=0.340 for Arthritis Self Efficacy Function
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.806
Comments p=0.806 for Arthritis Self Efficacy Other Symptoms
Method Mixed Models Analysis
Comments [Not Specified]
30.Secondary Outcome
Title Outcome Expectancy at 52 Weeks
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Measured by the Perceived Therapeutic Efficacy Scale in terms of the following:

Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better

Time Frame 6 months after the intervention period ends (week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description:

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Overall Number of Participants Analyzed 91 91
Mean (Standard Error)
Unit of Measure: units on a scale
Perceived Therapeutic Efficacy Arthritis 67.09  (2.83) 55.86  (3.07)
Perceived Therapeutic Efficacy Hypertension 73.40  (2.53) 67.93  (2.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection STAR Intervention, Attention-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension
Method t-test, 1 sided
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title STAR Intervention Attention-Control
Hide Arm/Group Description

Staying Active with Arthritis Intervention

STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Senior Health Information Intervention

Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

All-Cause Mortality
STAR Intervention Attention-Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
STAR Intervention Attention-Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)   0/91 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
STAR Intervention Attention-Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)   0/91 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth A. Schlenk
Organization: University of Pittsburgh
Phone: 412-624-4103
EMail: els100@pitt.edu
Layout table for additonal information
Responsible Party: Elizabeth Schlenk, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01280903    
Other Study ID Numbers: 1R01NR010904-01A1 ( U.S. NIH Grant/Contract )
R01NR010904-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 17, 2010
First Posted: January 21, 2011
Results First Submitted: December 13, 2016
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018