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

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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

Brief Summary:
The purpose of the Staying Active with Arthritis (STAR) research study is to determine if a 6-month program will improve leg exercise, fitness walking, and clinical outcomes (function, blood pressure, leg strength, pain, fatigue, and health-related quality of life) in older adults with osteoarthritis of the knee and high blood pressure.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Hypertension Behavioral: STAR Intervention Behavioral: Attention-Control Not Applicable

Detailed Description:
Over 9 million Americans have symptomatic osteoarthritis (OA) of the knee, a chronic disease associated with frequent joint pain, functional limitations, and quadriceps weakness that intrude upon everyday life. At least half of those with OA of the knee are diagnosed with hypertension or high blood pressure (HBP), one of the most prevalent risk factors for cardiovascular disease. Many other individuals with OA of the knee unknowingly have HBP and remain untreated. Our own work and that of others suggest that persons with OA of the knee experience reductions in BP when they participate in a regular regimen of physical activity. Even small decreases in systolic and diastolic BP found with physical activity are clinically significant, e.g., a 2 mm Hg decrease reduces the risk of stroke by 14% - 17%, and the risk of coronary heart disease is reduced by 6% - 9%. Yet, only 15% of persons with OA and 47% with HBP engage in regular physical activity. The purpose of this study is to investigate how the individually delivered, home-based, 6-month modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid HBP, affects lower extremity exercise (flexibility, strengthening, and balance), fitness walking, functional status, BP, quadriceps strength, pain, fatigue, and health-related quality of life (HRQoL) in a convenience sample of 224 adults age 50 years or older with OA of the knee and HBP. Using a randomized controlled, 2-group design, we (1) hypothesize that at the end of the 6-month intervention period and 6 months after the intervention period ends those who receive the modified STAR intervention will be more likely to perform lower extremity exercise, participate in fitness walking, show improvements in objective functional status, and demonstrate reductions in BP than those who receive attention-control. Secondarily, we will (2) evaluate the impact of the modified STAR intervention, compared to attention-control, on subjective functional status, quadriceps strength, pain, fatigue, and HRQoL at both time points; (3) explore the impact of the modified STAR intervention, compared to attention-control, on self-efficacy and outcome expectancy at both time points; (4) explore the relationship between self-efficacy and outcome expectancy; and (5) explore the extent to which self-efficacy and outcome expectancy mediate the relationship between the modified STAR intervention and performance of lower extremity exercise and participation in fitness walking. Data will be analyzed using repeated measures modeling.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Physical Activity in Older Adults With Comorbidity
Study Start Date : January 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: STAR Intervention
Staying Active with Arthritis Intervention
Behavioral: 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.
Placebo Comparator: Attention-Control
Senior Health Information Intervention
Behavioral: 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.



Primary Outcome Measures :
  1. Performance of Lower Extremity Exercise at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    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).

  2. Participation in Fitness Walking at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    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.

  3. Objective Functional Status by the 6-minute Walk at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.

  4. Objective Functional Status by the Short Physical Performance Battery at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    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.

  5. Systolic Blood Pressure at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  6. Diastolic Blood Pressure at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  7. Performance of Lower Extremity Exercise at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    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).

  8. Participation in Fitness Walking at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    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.

  9. Objective Functional Status by the 6-minute Walk at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.

  10. Objective Functional Status by the Short Physical Performance Battery at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    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.

  11. Systolic Blood Pressure at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  12. Diastolic Blood Pressure at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.


Secondary Outcome Measures :
  1. Subjective Functional Status at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    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.

  2. Quadriceps Strength at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.

  3. Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    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.

  4. Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.

  5. Fatigue at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]
    Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.

  6. Health-Related Quality of Life at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]

    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


  7. Self-Efficacy at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]

    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


  8. Arthritis Self-Efficacy at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]

    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


  9. Outcome Expectancy at 25 Weeks [ Time Frame: At the end of the 6-month intervention period (week 25) ]

    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


  10. Subjective Functional Status at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    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.

  11. Quadriceps Strength at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.

  12. Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    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.

  13. Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.

  14. Fatigue at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]
    Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.

  15. Health-Related Quality of Life at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]

    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


  16. Self-Efficacy at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]

    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


  17. Arthritis Self-Efficacy at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]

    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


  18. Outcome Expectancy at 52 Weeks [ Time Frame: 6 months after the intervention period ends (week 52) ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50 years or older.
  • Is community dwelling.
  • Has osteoarthritis of the knee.
  • Has hypertension for which monotherapy or combination pharmacological treatment is prescribed.
  • Able to complete a behavioral run-in consisting of completing questionnaires, using a 7-day electronic-diary, and wearing an ActiGraph accelerometer at the waist for 7 days.
  • Has written permission to participate from the physician.

Exclusion Criteria:

  • Reports currently doing lower extremity exercise => 2 times/week.
  • Reports currently fitness walking => 90 minutes/week.
  • Incapable of managing their own treatment regimen.
  • Does not have, or cannot use, a telephone or is unwilling to provide a telephone number.
  • Has received cortisone or Synvisc injections in the knee, angioplasty, stents, or a pacemaker in the past 6 months.
  • Reports unstable cardiovascular, pulmonary, or metabolic disease or signs and symptoms suggestive of cardiovascular, pulmonary, or metabolic disease that restrict activity.
  • Has resting systolic blood pressure => 160 mm Hg or diastolic blood pressure => 100 mm Hg.
  • Reports other conditions, such as osteoarthritis of the hip, spinal stenosis, inflammatory arthritis, foot drop, diabetes treated with insulin, or diabetic complications that may affect performance of lower extremity exercise and participation in fitness walking.
  • Reports current knee conditions, such as meniscus tears and knee ligament ruptures.
  • Reports major depression that may impact the ability to fully participate in this study.
  • Is scheduled to undergo a major surgical procedure in the next 13 months.
  • Is concurrently participating in a drug or psychoeducational trial that may confound, or be confounded by, participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280903


Locations
United States, Pennsylvania
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Elizabeth A. Schlenk, PhD, RN University of Pittsburgh

Responsible Party: Elizabeth Schlenk, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01280903     History of Changes
Other Study ID Numbers: 1R01NR010904-01A1 ( U.S. NIH Grant/Contract )
R01NR010904-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2011    Key Record Dates
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elizabeth Schlenk, University of Pittsburgh:
Osteoarthritis, Knee
Hypertension
Exercise
Physical activity
Self Efficacy
Patient Compliance
Aged

Additional relevant MeSH terms:
Hypertension
Osteoarthritis
Osteoarthritis, Knee
Vascular Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases