The Effect of Different Post-exercise Oral Nutritional Supplement Intake Timing on Sarcopenia Indicators in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Appendicular skeletal muscle mass
研究概览
简要总结
Objective: To assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients.
Study Design: 24-weeks Randomized Control Trial (RCT), includes 12-wk intervention period and 12-week follow up period.
Setting & Participants: Maintenance hemodialysis patients who were older than 20 years old meet sarcopenia diagnosis criteria.
Intervention: Group A: During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement in 1 to 2 hours after exercise program. Group B: Participants have the same exercise program and oral supplement as Group A. However, they take oral supplement in 2.5-4 hours after exercise program. Group C: Participants only take oral supplement. Control group: Participants maintain usual diet and physical activity without any intervention.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis treatment longer than 3 months
- •Hemodialysis treatment 3 times treatment per weeks
- •Kt/V≥1.2 or URR≥65%
- •Taking foods by oral
- •Meeting the criteria of sarcopenia.
排除标准
- •Soy allergy
- •Amputation
- •Significantly edema
- •Receiving palliative care
- •Severe angina
- •Unstable arrhythmias
- •Severe infection
- •Heart failure (class 4 of New York Heart Association scale)
- •Central venous catheter or femoral arteriovenous fistula
- •Pacemaker
- •Pregnancy
- •Severe paleness
- •Severe difficulty breathing
- •Chest pain
- •Hospitalization 3 months before recruited in this study
- •Oral supplement intolerance diagnosed by the doctor or dietitian
- •Bone injury/nerve damage/cognition impairment affecting physical activity intervention
结局指标
主要结局
Appendicular skeletal muscle mass
时间窗: Change from baseline appendicular skeletal muscle mass at 6 months
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Muscle strength
时间窗: Change from baseline muscle strength at 6 months
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Physical performance
时间窗: Change from baseline physical performance at 6 months
Measuring whether the of 6-metre walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
次要结局
未报告次要终点
研究者
Pei-Yu Wu
Project Assistant Professor
China Medical University Hospital