Weight Loss and Exercise in Frail Obese Elderly Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- physical function
研究概览
简要总结
The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.
详细描述
Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese (BMI 30 or greater)
- •Elderly (age 65 years or older)
排除标准
- •Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
- •Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.
结局指标
主要结局
physical function
时间窗: one year
次要结局
- body composition(one year)
- muscle protein synthesis(one year)
- quality of life(one year)
- cognition and mood(one year)
- metabolism(one year)
- bone mineral density(1 year)
研究者
Dennis T. Villareal
Associate Professor
Washington University School of Medicine