The Effects of Intradialytic Exercise on Daily Physical Activity in Patients Undergoing Long-term High-efficiency Online Hemodiafiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change of daily physical activity at 6 months
研究概览
简要总结
Low physical activity is associated with in hemodialysis and hemodiafiltration (HDF) patients. Previous studies showed the benefits of intradialytic exercise for improvement of physical fitness and hemodialysis adequacy. However, the effect of intradialytic exercise on physical activity has not been explored. This current open-labelled randomized controlled trial is conducted in HDF patients to determine the effect of intradialytic exercise program for 6 months on daily physical activity measured by tri-axial accelerometer (wearable device).
详细描述
The study is an open-labelled randomized controlled trial which compare the changes of daily physical activity measured by tri-axial accelerometer (wearable device) between the HDF patients in intradialytic exercise group and control during the 6-month period. After inclusion in to the study, all of the participants will be evaluated before randomized. The investigators will prescribe the exercise program for each participant in the exercise group. The exercise program use intradialytic cycling which will be gradually increased to at least 30 minutes with moderate intensity. The participants in control group will receive dialysis as usual without intradialytic exercise prescription. The participants will go on the program for at least 6-months period. In each session, any adverse event or side effect will be reported.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis vintage more than 3 months
- •Sedentary or light physical activity
排除标准
- •recent myocardial infarction (<12 months)
- •recent ischemic stroke (<12months)
- •uncontrolled comorbidities (diabetes/hypertension/heart failure/heart disease/respiratory disease)
- •Life expectancy < 12 months
- •active musculoskeletal problem e.g.) rheumatoid arthritis, spondyloarthropathy, osteoarthritis, fracture
研究组 & 干预措施
Intradialytic exercise group
These patients will get intradialytic exercise every sessions of hemodiafiltration
干预措施: Intradialytic exercise (Behavioral)
Standard dialysis group
regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise.
结局指标
主要结局
Change of daily physical activity at 6 months
时间窗: at 0 and 6 months
Every participant will be monitored their daily physical activity by wearable tri-axial accelerometer (Fitbit) before and at 6 months to observe changes in daily physical activity.
次要结局
- Dialysis adequacy as measured by kt/V(at 6 months)
- Aerobic exercise capacity as measured by VO2 max(at 6 months)
- Body composition (lean and fat body mass)(at 6 months)
研究者
Khajohn Tiranathanagul
Associate Professor
Chulalongkorn University