Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, weight-loss, exercise, obesity, physical function, total mortality
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.
Interventions
BEHAVIORALDietary Weight-loss
The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.
BEHAVIORALExercise
Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| self-reported physical function (WOMAC scale) | baseline, 6-months, 18-months |
Secondary
| Measure | Time frame |
|---|---|
| timed stair climbing | baseline, 6-months, 18-months |
| weight-loss | baseline, 6-months, 18-months |
| self-reported pain | 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 |
| progression of knee osteoarthritis, measured radiographically | baseline, 6-months, 18-months |
Countries
United States
Outcome results
None listed