Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- insulin sensitivity as assessed by surrogates of insulin sensitivity
研究概览
简要总结
Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •body mass index ≥ 35 kg/m2
- •not engaged in physical activity programs
- •without any physical limitation that could preclude exercise participation
排除标准
- •body mass index < 35 kg/m2
- •regular participation in physical activities programs
- •cancer or any other disease that could limit participation in exercise
研究组 & 干预措施
exercise training
Subjects will undergo bariatric surgery and exercise training will be prescribed.
干预措施: Exercise training (Other)
control
Subjects will undergo bariatric surgery and no exercise training will be prescribed.
结局指标
主要结局
insulin sensitivity as assessed by surrogates of insulin sensitivity
时间窗: 6 months
body composition as assessed by densitometry (DEXA)
时间窗: 6 months
bone mass, lean mass and fat mass
profile of cytokines
时间窗: 6 months
次要结局
- muscle function as assessed by a battery of tests(6 months)
- depression and anxiety as assessed by questionnaires (composite)(6 months)
- quality of life as assessed by questionnaires (composite)(6 months)
- risk of cardiovascular events as assessed by questionnaires (composite)(6 months)
- physical activity level as assessed by accelerometry(6 months)
- aerobic conditioning as assessed by a cardiopulmonary test.(6 months)
研究者
Bruno Gualano
Professor
University of Sao Paulo