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Comparison of Treatments Following Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT02237911
Recruitment Status : Completed
First Posted : September 11, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sara R. Piva, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Degeneration; Articular Cartilage, Knee
Rheumatoid Arthritis
Osteoarthritis, Knee
Interventions Other: Clinic-based outpatient exercise group
Other: Community-based exercise group
Enrollment 240
Recruitment Details Potential subjects were identified from their surgeons' office or via public announcement in the greater Pittsburgh area, from December 2014 through February 2017. If interested in the study, subjects called the research team to obtain more information about the study, and were then screened for study eligibility.
Pre-assignment Details A total of 1372 subjects called for study information: 89 could not be contacted and 1283 were screened over the telephone. From those, 1032 were not eligible/willing to participate and 251 completed in-person screening. Eleven subjects failed in-person screening, resulting in 240 eligible subjects that were randomized into one of the study arms.
Arm/Group Title Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Hide Arm/Group Description Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. Wait-listed usual medical care - no intervention provided by study.
Period Title: Overall Study
Started 96 96 48
3 Months 90 87 44
6 Months 89 88 45
Completed 89 88 45
Not Completed 7 8 3
Reason Not Completed
Withdrawal by Subject             4             7             2
Lost to Follow-up             3             1             1
Arm/Group Title Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care Total
Hide Arm/Group Description Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and included exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consisted of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. Wait-listed usual medical care - no intervention provided by study. Total of all reporting groups
Overall Number of Baseline Participants 96 96 48 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 96 participants 48 participants 240 participants
69  (6.3) 70  (7.0) 70  (6.6) 70  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 48 participants 240 participants
Female
59
  61.5%
58
  60.4%
31
  64.6%
148
  61.7%
Male
37
  38.5%
38
  39.6%
17
  35.4%
92
  38.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 48 participants 240 participants
Hispanic or Latino
0
   0.0%
1
   1.0%
1
   2.1%
2
   0.8%
Not Hispanic or Latino
96
 100.0%
95
  99.0%
47
  97.9%
238
  99.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 48 participants 240 participants
American Indian or Alaska Native
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  10.4%
18
  18.8%
11
  22.9%
39
  16.3%
White
86
  89.6%
77
  80.2%
37
  77.1%
200
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 48 participants 240 participants
Less than college
31
  32.3%
33
  34.4%
12
  25.0%
76
  31.7%
Complete college or technical training
59
  61.5%
57
  59.4%
31
  64.6%
147
  61.3%
Other/missing
6
   6.3%
6
   6.3%
5
  10.4%
17
   7.1%
Marital status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 48 participants 240 participants
Married
64
  66.7%
62
  64.6%
31
  64.6%
157
  65.4%
Divorced
18
  18.8%
12
  12.5%
7
  14.6%
37
  15.4%
Widowed
8
   8.3%
14
  14.6%
6
  12.5%
28
  11.7%
Never Married
4
   4.2%
8
   8.3%
3
   6.3%
15
   6.3%
Other
2
   2.1%
0
   0.0%
1
   2.1%
3
   1.3%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 96 participants 96 participants 48 participants 240 participants
30.8  (5.3) 31.1  (6.3) 31.5  (5.1) 31.1  (5.7)
Cumulative Illness Rating Scale  
Mean (Standard Deviation)
Unit of measure:  Number of comorbidities
Number Analyzed 96 participants 96 participants 48 participants 240 participants
4.3  (2.0) 4.4  (1.7) 4.6  (1.9) 4.4  (1.9)
Total Knee Replacement Due To  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 96 participants 48 participants 240 participants
Osteoarthritis
92
  95.8%
92
  95.8%
48
 100.0%
232
  96.7%
Inflammatory Arthritis
4
   4.2%
4
   4.2%
0
   0.0%
8
   3.3%
Surgical Knee Flexion  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 96 participants 96 participants 48 participants 240 participants
124  (11) 123  (11) 124  (10) 124  (11)
Surgical knee pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 96 participants 96 participants 48 participants 240 participants
2.7  (2.1) 2.3  (1.7) 2.2  (1.8) 2.4  (1.9)
[1]
Measure Description: Numeric Pain Rating Scale (NPRS). Current pain intensity was measure by NRPS. Score ranged from 0 to 10, 0 representing no pain, and 10 representing worse pain imaginable.
1.Primary Outcome
Title The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
Hide Description WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
Time Frame Baseline, 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat approach was used among participants with follow-up data.
Arm/Group Title Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Hide Arm/Group Description:
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
Wait-listed usual medical care - no intervention provided by study.
Overall Number of Participants Analyzed 96 96 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 96 participants 96 participants 48 participants
20.9  (7.9) 20.4  (7.4) 20.2  (7.9)
3 months Number Analyzed 90 participants 87 participants 44 participants
10.1  (6.6) 12.2  (7.9) 11.9  (7.6)
6 months Number Analyzed 89 participants 88 participants 45 participants
9.8  (7.2) 10.8  (7.9) 11.8  (7.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.1
Confidence Interval (2-Sided) 98.3%
-4.9 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Wait-listed Usual Medical Care
Comments Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.1
Confidence Interval (2-Sided) 98.3%
-5.0 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Community-based Exercise Group, Wait-listed Usual Medical Care
Comments Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 98.3%
-2.7 to 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Community-based Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.491
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 98.3%
-3.7 to 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Community-based Exercise Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.2
Confidence Interval (2-Sided) 98.3%
-4.5 to 0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Community-based Exercise Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 98.3%
-3.6 to 1.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Composite Score of Performed-based Tests of Physical Function.
Hide Description Scores on 6 performance-based tests (i.e., the 6-minute walk test, 40-meter gait speed, stair ascend/descend test, single leg stance balance test, chair stand test, and floor sitting-rising) were combined into a composite score formed with the unit-weighted Z scores of constituent tests to provide a more representative and stable measure of the subjects' underlying functional performance. The unit weights refer to averaging standardized scores (e.g., the scores for each performance-based test are converted to Z-scores before applying equal weights). Higher Z-scores represent better functional performance. The Z-scores for each participant can be interpreted as deviations from the baseline average of the whole group. We considered a change in Z-score of 0.2 as clinically important because it represents approximately 20% of a standard deviation relative to the baseline average of the whole group.
Time Frame Baseline, 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat approach was used among participants with follow-up data.
Arm/Group Title Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Hide Arm/Group Description:
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
Wait-listed usual medical care - no intervention provided by study.
Overall Number of Participants Analyzed 96 96 48
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 96 participants 96 participants 48 participants
0.02  (0.8) -0.06  (0.8) -0.11  (0.7)
3 months Number Analyzed 89 participants 87 participants 44 participants
0.49  (0.7) 0.3  (0.8) 0.13  (0.7)
6 months Number Analyzed 83 participants 76 participants 40 participants
0.5  (0.8) 0.36  (0.9) 0.25  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 98.3%
0.1 to 0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 98.3%
0.01 to 0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Community-based Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 98.3%
0.02 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Community-based Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 98.3%
-0.003 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Community-based Exercise Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 98.3%
0.02 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Community-based Exercise Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.489
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 98.3%
-0.003 to 0.3
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear).
Hide Description Real-time measure of daily energy expenditure physical activity assessed by portable activity monitor.
Time Frame Baseline, 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat approach was used among participants with follow-up data.
Arm/Group Title Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Hide Arm/Group Description:
Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
Wait-listed usual medical care - no intervention provided by study.
Overall Number of Participants Analyzed 96 96 48
Mean (Standard Deviation)
Unit of Measure: Kcal/day
Baseline Number Analyzed 96 participants 95 participants 47 participants
511  (411) 541  (419) 459  (352)
3 months Number Analyzed 85 participants 86 participants 43 participants
566  (451) 547  (407) 525  (411)
6 months Number Analyzed 84 participants 79 participants 40 participants
538  (403) 480  (420) 509  (518)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.943
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4
Confidence Interval (2-Sided) 95%
-106 to 114
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15
Confidence Interval (2-Sided) 95%
-112 to 142
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Community-based Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.787
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15
Confidence Interval (2-Sided) 95%
-125 to 95
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Community-based Exercise Group, Wait-listed Usual Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -36
Confidence Interval (2-Sided) 95%
-164 to 92
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Community-based Exercise Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19
Confidence Interval (2-Sided) 95%
-71 to 109
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Clinic-based Outpatient Exercise Group, Community-based Exercise Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments [Not Specified]
Method Mixed Models Analysis
Comments Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 51
Confidence Interval (2-Sided) 95%
-52 to 154
Estimation Comments [Not Specified]
Time Frame The adverse events were collected during subjects participation in the study (over 6 months).
Adverse Event Reporting Description The study used a standard questionnaire to monitor AEs every 1.5 months.
 
Arm/Group Title Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Hide Arm/Group Description Clinic-based outpatient exercise group: Subjects participated in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session lasted about 60 minutes. Treatment sessions utilized a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills. Community-based exercise group: Subjects attended to exercise classes (community-based) 2 times per week during 3 months. The exercise classes lasted approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living. Wait-listed usual medical care - no intervention provided by study.
All-Cause Mortality
Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)      0/96 (0.00%)      0/48 (0.00%)    
Hide Serious Adverse Events
Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/96 (5.21%)      4/96 (4.17%)      5/48 (10.42%)    
Gastrointestinal disorders       
Gastroesophageal Reflux Disease   1/96 (1.04%)  1 0/96 (0.00%)  0 0/48 (0.00%)  0
Gastrointestinal Disorders   1/96 (1.04%)  1 1/96 (1.04%)  1 0/48 (0.00%)  0
Injury, poisoning and procedural complications       
Fall   0/96 (0.00%)  0 0/96 (0.00%)  0 1/48 (2.08%)  1
Injury, poisoning and procedural complication   1/96 (1.04%)  1 0/96 (0.00%)  0 0/48 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorder   0/96 (0.00%)  0 0/96 (0.00%)  0 1/48 (2.08%)  1
Renal and urinary disorders       
Urinary tract infection   0/96 (0.00%)  0 0/96 (0.00%)  0 1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders       
Sleep apnea   0/96 (0.00%)  0 1/96 (1.04%)  1 0/48 (0.00%)  0
Skin and subcutaneous tissue disorders       
Wound infection   0/96 (0.00%)  0 0/96 (0.00%)  0 1/48 (2.08%)  1
Surgical and medical procedures       
Surgical and medical procedures   1/96 (1.04%)  1 1/96 (1.04%)  1 0/48 (0.00%)  0
Vascular disorders       
Thromboembolic event   1/96 (1.04%)  1 1/96 (1.04%)  1 1/48 (2.08%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clinic-based Outpatient Exercise Group Community-based Exercise Group Wait-listed Usual Medical Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/96 (40.63%)      42/96 (43.75%)      22/48 (45.83%)    
Eye disorders       
Cataract   1/96 (1.04%)  1 3/96 (3.13%)  3 3/48 (6.25%)  3
Musculoskeletal and connective tissue disorders       
Arthralgia   18/96 (18.75%)  18 17/96 (17.71%)  18 8/48 (16.67%)  8
Back Pain   7/96 (7.29%)  7 9/96 (9.38%)  9 5/48 (10.42%)  5
Other musculoskeletal and connective tissue disorder   13/96 (13.54%)  13 13/96 (13.54%)  13 6/48 (12.50%)  6
Indicates events were collected by systematic assessment
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: Dr. Sara Piva
Organization: University of Pittsburgh
Phone: (412) 383-6712
EMail: spiva@pitt.edu
Layout table for additonal information
Responsible Party: Sara R. Piva, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02237911    
Other Study ID Numbers: PRO14080261
CER-1310-06994 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Submitted: September 9, 2014
First Posted: September 11, 2014
Results First Submitted: December 31, 2017
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019