The Arthritis, Diet, and Activity Promotion Trial

Wake Forest University Health Sciences1 个研究点分布在 1 个国家目标入组 318 人1997年11月

适应症Knee Osteoarthritis

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Knee Osteoarthritis
发起方: Wake Forest University Health Sciences
入组人数: 318
试验地点: 1
主要终点: self-reported physical function (WOMAC scale)
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

1997年11月

结束日期

2000年12月

最后更新

3年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Wake Forest University Health Sciences

责任方

Sponsor

入排标准

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)