Relationship Between Physical Activity and Health Outcomes in Overweight and Obese Medically Complex Adults, a Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Gait, Grip and Walking
研究概览
简要总结
Obesity is common in adults with complex medical problems with ensuing complications afterwards. Obese patients suffer higher mortality and impaired functional status often as a result of their obesity. One primary goal to reduce both obesity and improve functional status is exercise. The investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. As a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and ER visits.
详细描述
We are enrolling up to 150 subjects where half will receive a pedometer and behavioral goal-setting at enrollment and half will receive a pedometer and goal-setting 2 months later. It is a 4 month study. Our aims are as follows:
Primary Aim: Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.
Second Primary aim: To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.
Secondary Aim: Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will be over the age of 18
- •Have a BMI over 25.0 kg/m
- •Have a Minnesota Medical Tiering concerning medical complexity of 3-4.
排除标准
- •Patients will be excluded if they have clinically documented dementia.
- •Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
- •Subjects residing within a correctional institution will be excluded.
- •Subject is a female patient who is currently pregnant.
结局指标
主要结局
Gait, Grip and Walking
时间窗: 4 months
Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.
weight loss
时间窗: 4 months
To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.
次要结局
- number of hospitalizations(4 months)
研究者
Paul Takahashi,
Principal Investigator
Mayo Clinic