NCT00979043已完成不适用
The Arthritis, Diet, and Activity Promotion Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- self-reported physical function (WOMAC scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years.
- •BMI ≥ 28 kg/m
- •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.
排除标准
- •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 <
- •Inability to walks without a cane.
- •Reported alcohol consumption >14 drinks/week.
- •Inability to complete protocol.
- •ST segment depression.
- •Participation in another research study.
结局指标
主要结局
self-reported physical function (WOMAC scale)
时间窗: baseline, 6-months, 18-months
次要结局
- 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)
研究者
研究点 (2)
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