CClinicalTrials.gg
CompletedNCT01280903STARUpdated Sep 19, 2024Results posted

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

An interventional study of STAR Intervention and Attention-Control in Osteoarthritis, Knee and Hypertension, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis, Knee
  • Hypertension

Keywords

  • Osteoarthritis, Knee
  • Hypertension
  • Exercise
  • Physical activity
  • Self Efficacy
  • Patient Compliance
  • Aged
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 182 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
182 participants (actual)

Study arms

  • Experimental
    STAR Intervention

    Staying Active with Arthritis Intervention

    Behavioral: STAR Intervention

  • Placebo comparator
    Attention-Control

    Senior Health Information Intervention

    Behavioral: Attention-Control

Interventions

  • BehavioralSTAR 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.

  • BehavioralAttention-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.

06

What researchers measure

Primary outcomes

  1. Performance of Lower Extremity Exercise at 25 Weeks

    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)

  2. Participation in Fitness Walking at 25 Weeks

    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)

  3. Objective Functional Status by the 6-minute Walk at 25 Weeks

    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)

  4. Objective Functional Status by the Short Physical Performance Battery at 25 Weeks

    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)

  5. Systolic Blood Pressure at 25 Weeks

    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)

  6. Diastolic Blood Pressure at 25 Weeks

    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)

  7. Performance of Lower Extremity Exercise at 52 Weeks

    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)

  8. Participation in Fitness Walking at 52 Weeks

    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)

  9. Objective Functional Status by the 6-minute Walk at 52 Weeks

    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)

  10. Objective Functional Status by the Short Physical Performance Battery at 52 Weeks

    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)

  11. Systolic Blood Pressure at 52 Weeks

    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)

  12. Diastolic Blood Pressure at 52 Weeks

    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)

Secondary outcomes

  1. Subjective Functional Status at 25 Weeks

    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)

  2. Quadriceps Strength at 25 Weeks

    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)

  3. Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks

    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)

  4. Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks

    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)

  5. Fatigue at 25 Weeks

    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)

  6. Health-Related Quality of Life at 25 Weeks

    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)

  7. Self-Efficacy at 25 Weeks

    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)

  8. Arthritis Self-Efficacy at 25 Weeks

    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)

  9. Outcome Expectancy at 25 Weeks

    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)

  10. Subjective Functional Status at 52 Weeks

    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)

  11. Quadriceps Strength at 52 Weeks

    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)

  12. Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks

    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)

  13. Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks

    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)

  14. Fatigue at 52 Weeks

    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)

  15. Health-Related Quality of Life at 52 Weeks

    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)

  16. Self-Efficacy at 52 Weeks

    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)

  17. Arthritis Self-Efficacy at 52 Weeks

    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)

  18. Outcome Expectancy at 52 Weeks

    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)

07

Results

Posted Jan 31, 2018

Participant flow

Participant flow — Overall Study
MilestoneSTAR InterventionAttention-Control
Started9191
Completed6875
Not completed2316
Withdrew: Lost to follow-up2316

Outcome measures

PrimaryPerformance of Lower Extremity Exercise at 25 Weeks

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)
Reported as:
Mean · repetitions x sets/week
Performance of Lower Extremity Exercise at 25 Weeks
repetitions x sets/weekSTAR InterventionAttention-Control
Performance of Lower Extremity Exercise at 25 Weeks46.84 ± 4.591.90 ± 0.86
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = <.0001
PrimaryParticipation in Fitness Walking at 25 Weeks

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)
Reported as:
Mean · minutes
Participation in Fitness Walking at 25 Weeks
minutesSTAR InterventionAttention-Control
None to very low434.89 ± 11.69409.98 ± 11.54
Light314.07 ± 9.29321.44 ± 9.18
Moderate-to-vigorous40.53 ± 2.6846.69 ± 3.93
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.130 (p=0.130 for None to very low)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.573 (p=0.573 for Light)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.197 (p=0.197 for Moderate-to-vigorous)
PrimaryObjective Functional Status by the 6-minute Walk at 25 Weeks

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)
Reported as:
Mean · yards
Objective Functional Status by the 6-minute Walk at 25 Weeks
yardsSTAR InterventionAttention-Control
Objective Functional Status by the 6-minute Walk at 25 Weeks465.46 ± 18.82483.02 ± 14.47
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.461
PrimaryObjective Functional Status by the Short Physical Performance Battery at 25 Weeks

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)
Reported as:
Mean · units on a scale
Objective Functional Status by the Short Physical Performance Battery at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Objective Functional Status by the Short Physical Performance Battery at 25 Weeks11.29 ± 0.2210.86 ± 0.23
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.180
PrimarySystolic Blood Pressure at 25 Weeks

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)
Reported as:
Mean · mm Hg
Systolic Blood Pressure at 25 Weeks
mm HgSTAR InterventionAttention-Control
Systolic Blood Pressure at 25 Weeks120.33 ± 1.74123.07 ± 1.68
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.258
PrimaryDiastolic Blood Pressure at 25 Weeks

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)
Reported as:
Mean · mm Hg
Diastolic Blood Pressure at 25 Weeks
mm HgSTAR InterventionAttention-Control
Diastolic Blood Pressure at 25 Weeks71.74 ± 1.2073.10 ± 1.16
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.416
PrimaryPerformance of Lower Extremity Exercise at 52 Weeks

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)
Reported as:
Mean · repetitions x sets/week
Performance of Lower Extremity Exercise at 52 Weeks
repetitions x sets/weekSTAR InterventionAttention-Control
Performance of Lower Extremity Exercise at 52 Weeks42.06 ± 6.743.14 ± 1.22
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = <.0001
PrimaryParticipation in Fitness Walking at 52 Weeks

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)
Reported as:
Mean · minutes
Participation in Fitness Walking at 52 Weeks
minutesSTAR InterventionAttention-Control
None to very low426.71 ± 11.97408.30 ± 11.70
Light318.04 ± 9.50321.01 ± 9.30
Moderate-to-vigorous39.37 ± 2.7447.97 ± 3.97
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.272 (p=0.272 for None to very low)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.823 (p=0.823 for Light)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.076 (p=0.076 for Moderate-to-vigorous)
PrimaryObjective Functional Status by the 6-minute Walk at 52 Weeks

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)
Reported as:
Mean · yards
Objective Functional Status by the 6-minute Walk at 52 Weeks
yardsSTAR InterventionAttention-Control
Objective Functional Status by the 6-minute Walk at 52 Weeks480.29 ± 16.89465.36 ± 19.26
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.561
PrimaryObjective Functional Status by the Short Physical Performance Battery at 52 Weeks

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)
Reported as:
Mean · units on a scale
Objective Functional Status by the Short Physical Performance Battery at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Objective Functional Status by the Short Physical Performance Battery at 52 Weeks11.20 ± 0.2411.25 ± 0.19
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.856
PrimarySystolic Blood Pressure at 52 Weeks

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)
Reported as:
Mean · mm Hg
Systolic Blood Pressure at 52 Weeks
mm HgSTAR InterventionAttention-Control
Systolic Blood Pressure at 52 Weeks122.54 ± 1.78125.14 ± 1.71
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.292
PrimaryDiastolic Blood Pressure at 52 Weeks

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)
Reported as:
Mean · mm Hg
Diastolic Blood Pressure at 52 Weeks
mm HgSTAR InterventionAttention-Control
Diastolic Blood Pressure at 52 Weeks72.62 ± 1.2274.06 ± 1.18
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.396
SecondarySubjective Functional Status at 25 Weeks

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)
Reported as:
Mean · units on a scale
Subjective Functional Status at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Subjective Functional Status at 25 Weeks16.68 ± 1.4418.30 ± 1.42
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.424
SecondaryQuadriceps Strength at 25 Weeks

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)
Reported as:
Mean · pounds
Quadriceps Strength at 25 Weeks
poundsSTAR InterventionAttention-Control
Quadriceps Strength at 25 Weeks43.21 ± 1.7541.88 ± 1.71
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.586
SecondaryPain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks

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)
Reported as:
Mean · units on a scale
Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks4.25 ± 0.394.54 ± 0.38
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.596
SecondaryPain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks

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)
Reported as:
Mean · units on a scale
Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks59.65 ± 2.3258.13 ± 2.26
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.639
SecondaryFatigue at 25 Weeks

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)
Reported as:
Mean · units on a scale
Fatigue at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Fatigue at 25 Weeks2.49 ± 0.272.76 ± 0.25
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.466
SecondaryHealth-Related Quality of Life at 25 Weeks

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)
Reported as:
Mean · units on a scale
Health-Related Quality of Life at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Short Form-36v2 Mental Component53.92 ± 1.1152.30 ± 1.20
Short Form-36v2 Physical Component43.10 ± 0.9743.07 ± 0.95
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.322 (p=0.322 for Short Form-36v2 Mental Component)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.979 (p=0.979 for Short Form-36v2 Physical Component)
SecondarySelf-Efficacy at 25 Weeks

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)
Reported as:
Mean · units on a scale
Self-Efficacy at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Exercise Barriers Self-Efficacy59.81 ± 2.7758.37 ± 2.69
Exercise Self-Efficacy67.43 ± 3.4460.20 ± 3.35
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.710 (p=0.710 for Exercise Barriers Self-Efficacy)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.133 (p=0.133 for Exercise Self-Efficacy)
SecondaryArthritis Self-Efficacy at 25 Weeks

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)
Reported as:
Mean · units on a scale
Arthritis Self-Efficacy at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Arthritis Self Efficacy Pain75.58 ± 1.9767.38 ± 2.13
Arthritis Self-Efficacy Function85.74 ± 1.7985.90 ± 1.67
Arthritis Self-Efficacy Other Symptoms78.88 ± 1.9977.66 ± 1.95
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.005 (p=0.005 for Arthritis Self Efficacy Pain)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.948 (p=0.948 for Arthritis Self Efficacy Function)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.663 (p=0.663 for Arthritis Self Efficacy Other Symptoms)
SecondaryOutcome Expectancy at 25 Weeks

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)
Reported as:
Mean · units on a scale
Outcome Expectancy at 25 Weeks
units on a scaleSTAR InterventionAttention-Control
Perceived Therapeutic Efficacy Arthritis72.79 ± 2.4159.67 ± 2.91
Perceived Therapeutic Efficacy Hypertension77.14 ± 2.4869.62 ± 2.42
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.001 (p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.031 (p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension)
SecondarySubjective Functional Status at 52 Weeks

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)
Reported as:
Mean · units on a scale
Subjective Functional Status at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Subjective Functional Status at 52 Weeks17.02 ± 1.4917.51 ± 1.44
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.816
SecondaryQuadriceps Strength at 52 Weeks

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)
Reported as:
Mean · pounds
Quadriceps Strength at 52 Weeks
poundsSTAR InterventionAttention-Control
Quadriceps Strength at 52 Weeks43.66 ± 1.7743.33 ± 1.73
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.895
SecondaryPain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks

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)
Reported as:
Mean · units on a scale
Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks4.09 ± 0.414.72 ± 0.39
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.260
SecondaryPain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks

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)
Reported as:
Mean · units on a scale
Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks59.73 ± 2.3659.70 ± 2.28
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.993
SecondaryFatigue at 52 Weeks

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)
Reported as:
Mean · units on a scale
Fatigue at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Fatigue at 52 Weeks2.97 ± 0.282.94 ± 0.25
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.947
SecondaryHealth-Related Quality of Life at 52 Weeks

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)
Reported as:
Mean · units on a scale
Health-Related Quality of Life at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Short Form-36v2 Mental Component53.18 ± 1.1251.81 ± 1.21
Short Form-36v2 Physical Component42.10 ± 1.1842.47 ± 1.15
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.406 (p=0.406 for Short Form-36v2 Mental Component)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.826 (p=0.826 for Short Form-36v2 Physical Component)
SecondarySelf-Efficacy at 52 Weeks

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)
Reported as:
Mean · units on a scale
Self-Efficacy at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Exercise Barriers Self-Efficacy53.30 ± 2.8353.05 ± 2.73
Exercise Self-Efficacy55.49 ± 3.5651.00 ± 3.43
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.950 (p=0.950 for Exercise Barriers Self-Efficacy)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.365 (p=0.365 for Exercise Self-Efficacy)
SecondaryArthritis Self-Efficacy at 52 Weeks

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)
Reported as:
Mean · units on a scale
Arthritis Self-Efficacy at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Arthritis Self-Efficacy Pain73.15 ± 2.0669.44 ± 2.19
Arthritis Self-Efficacy Function85.38 ± 1.8287.75 ± 1.69
Arthritis Self-Efficacy Other Symptoms75.92 ± 2.0375.23 ± 1.96
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.219 (p=0.219 for Arthritis Self Efficacy Pain)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.340 (p=0.340 for Arthritis Self Efficacy Function)
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.806 (p=0.806 for Arthritis Self Efficacy Other Symptoms)
SecondaryOutcome Expectancy at 52 Weeks

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)
Reported as:
Mean · units on a scale
Outcome Expectancy at 52 Weeks
units on a scaleSTAR InterventionAttention-Control
Perceived Therapeutic Efficacy Arthritis67.09 ± 2.8355.86 ± 3.07
Perceived Therapeutic Efficacy Hypertension73.40 ± 2.5367.93 ± 2.44
Statistical analysis
  • STAR Intervention vs Attention-Control · Mixed Models Analysis · p = 0.008 (p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis)
  • STAR Intervention vs Attention-Control · t-test, 1 sided · p = 0.120 (p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension)

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
STAR Intervention—0/91 (0%)0/91 (0%)
Attention-Control—0/91 (0%)0/91 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)STAR InterventionAttention-ControlTotal
Mean64.47 ± 8.4664.96 ± 7.7664.71 ± 8.10
Sex: Female, Male
Sex: Female, Male(Participants)STAR InterventionAttention-ControlTotal
Female6766133
Male242549
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)STAR InterventionAttention-ControlTotal
Hispanic or Latino336
Not Hispanic or Latino8888176
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)STAR InterventionAttention-ControlTotal
American Indian or Alaska Native101
Asian213
Native Hawaiian or Other Pacific Islander000
Black or African American171532
White6666132
More than one race5914
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)STAR InterventionAttention-ControlTotal
United States9191182
Body mass index
Body mass index(kg/m²)STAR InterventionAttention-ControlTotal
Mean34.50 ± 7.4833.64 ± 6.4334.07 ± 6.97
Number of comorbidities
Number of comorbidities(comorbidities)STAR InterventionAttention-ControlTotal
Mean6.8 ± 2.96.5 ± 2.76.6 ± 2.8
Marital status
Marital status(participants)STAR InterventionAttention-ControlTotal
Married384684
Not married534598

44 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Pittsburgh School of Nursing
    Pittsburgh, Pennsylvania 15261, United States
09

References and documents

Publications

  • Schlenk EA, Sereika SM, Martire LM, Shi X. Older adults' social network and support and its association with physical activity. Geriatr Nurs. 2021 Mar-Apr;42(2):517-523. doi: 10.1016/j.gerinurse.2020.09.006. Epub 2020 Oct 7. PubMed 33039202 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01280903
Lead sponsor
University of Pittsburgh
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Elizabeth Schlenk (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Jan 21, 2011
Start date
Jan 2012
Primary completion
Apr 2015
Completion
Apr 2015
Results posted
Jan 31, 2018
Last update
Sep 19, 2024

Study contacts

Elizabeth A. Schlenk, PhD, RN
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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