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
- 1
- 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
研究组 & 干预措施
Control group
Participants maintain usual diet and physical activity without any intervention
1 hour combined intervention ( Exercise and nutrition)
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 (103 kcal and 8.4 g of protein) in 1 to 2 hours after exercise program.
干预措施: 1 hour combined intervention ( Exercise and nutrition) (Other)
3 hours combined intervention ( Exercise and nutrition)
The only one different between "1 hour combined intervention" and this intervention is the time interval between exercise and nutrition. The time interval of "1 hour combined intervention" is 1 to 2 hour, and this intervention is 2.5-4 hours. Other procedure is totally the same.
干预措施: 3 hours combined intervention ( Exercise and nutrition) (Other)
Nutrition intervention
Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention".
干预措施: Nutrition intervention (Dietary Supplement)
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.
Appendicular skeletal muscle mass
时间窗: Change from baseline appendicular skeletal muscle mass at 3 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 3 months
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Physical performance
时间窗: Change from baseline physical performance at 3 months
Measuring whether the of 6-meter 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