The Arthritis, Diet, and Activity Promotion Trial
Not Applicable
Completed
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT00979043
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
Inclusion Criteria
- Age ≥ 60 years.
- BMI ≥ 28 kg/m2.
- Knee pain on most days of the month.
- Sedentary lifestyle pattern (<20 min exercise per week for last 6 months)
- Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care.
- Radiographic evidence of grade 1-3 knee osteoarthritis.
Exclusion Criteria
- Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes.
- Mini-mental state exam score <24.
- Inability to walks without a cane.
- Reported alcohol consumption >14 drinks/week.
- Inability to complete protocol.
- ST segment depression.
- Participation in another research study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method self-reported physical function (WOMAC scale) baseline, 6-months, 18-months
- Secondary Outcome Measures
Name Time Method self-reported pain baseline, 6-months, 18-months weight-loss baseline, 6-months, 18-months timed stair climbing baseline, 6-months, 18-months progression of knee osteoarthritis, measured radiographically baseline, 6-months, 18-months 6-minute walking distance baseline, 6-months, 18-months chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2 baseline and 18-months total mortality 7-9 yrs post-trial
Trial Locations
- Locations (1)
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University🇺🇸Winston-Salem, North Carolina, United States