N/A
N=182
Staying Active With Arthritis: RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension
Osteoarthritis, Knee · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01280903 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Performance of Lower Extremity Exercise at 25 Weeks — 46.84; 1.90 repetitions x sets/week — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STAR Intervention (Behavioral); Attention-Control (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance of Lower Extremity Exercise at 25 Weeks |
46.84; 1.90 | <.0001 sig |
| PRIMARY Participation in Fitness Walking at 25 Weeks |
434.89; 409.98; 314.07; 321.44; 40.53; 46.69 | 0.130 |
| PRIMARY Objective Functional Status by the 6-minute Walk at 25 Weeks |
465.46; 483.02 | 0.461 |
| PRIMARY Objective Functional Status by the Short Physical Performance Battery at 25 Weeks |
11.29; 10.86 | 0.180 |
| PRIMARY Systolic Blood Pressure at 25 Weeks |
120.33; 123.07 | 0.258 |
| PRIMARY Diastolic Blood Pressure at 25 Weeks |
71.74; 73.10 | 0.416 |
| PRIMARY Performance of Lower Extremity Exercise at 52 Weeks |
42.06; 3.14 | <.0001 sig |
| PRIMARY Participation in Fitness Walking at 52 Weeks |
426.71; 408.30; 318.04; 321.01; 39.37; 47.97 | 0.272 |
| PRIMARY Objective Functional Status by the 6-minute Walk at 52 Weeks |
480.29; 465.36 | 0.561 |
| PRIMARY Objective Functional Status by the Short Physical Performance Battery at 52 Weeks |
11.20; 11.25 | 0.856 |
| PRIMARY Systolic Blood Pressure at 52 Weeks |
122.54; 125.14 | 0.292 |
| PRIMARY Diastolic Blood Pressure at 52 Weeks |
72.62; 74.06 | 0.396 |
| SECONDARY Subjective Functional Status at 25 Weeks |
16.68; 18.30 | 0.424 |
| SECONDARY Quadriceps Strength at 25 Weeks |
43.21; 41.88 | 0.586 |
| SECONDARY Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks |
4.25; 4.54 | 0.596 |
| SECONDARY Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks |
59.65; 58.13 | 0.639 |
| SECONDARY Fatigue at 25 Weeks |
2.49; 2.76 | 0.466 |
| SECONDARY Health-Related Quality of Life at 25 Weeks |
53.92; 52.30; 43.10; 43.07 | 0.322 |
| SECONDARY Self-Efficacy at 25 Weeks |
59.81; 58.37; 67.43; 60.20 | 0.710 |
| SECONDARY Arthritis Self-Efficacy at 25 Weeks |
75.58; 67.38; 85.74; 85.90; 78.88; 77.66 | 0.005 sig |
| SECONDARY Outcome Expectancy at 25 Weeks |
72.79; 59.67; 77.14; 69.62 | 0.001 sig |
| SECONDARY Subjective Functional Status at 52 Weeks |
17.02; 17.51 | 0.816 |
| SECONDARY Quadriceps Strength at 52 Weeks |
43.66; 43.33 | 0.895 |
| SECONDARY Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks |
4.09; 4.72 | 0.260 |
| SECONDARY Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks |
59.73; 59.70 | 0.993 |
| SECONDARY Fatigue at 52 Weeks |
2.97; 2.94 | 0.947 |
| SECONDARY Health-Related Quality of Life at 52 Weeks |
53.18; 51.81; 42.10; 42.47 | 0.406 |
| SECONDARY Self-Efficacy at 52 Weeks |
53.30; 53.05; 55.49; 51.00 | 0.950 |
| SECONDARY Arthritis Self-Efficacy at 52 Weeks |
73.15; 69.44; 85.38; 87.75; 75.92; 75.23 | 0.219 |
| SECONDARY Outcome Expectancy at 52 Weeks |
67.09; 55.86; 73.40; 67.93 | 0.008 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01280903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.