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
- 1
- 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.
研究组 & 干预措施
self-exercise
Intervention will include a video(DVD) on exercise, and 2 self-help manuals on exercise and nutrition, in addition to a journal and pedometer.
干预措施: Self-Exercise (Behavioral)
usual care
Participants will have full access to all of the educational materials which are available to all Mayo Clinic patients in literature racks in the individual clinics.
干预措施: Usual Care (Behavioral)
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