A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Handgrip strength in Kg using a portable dyanometer
研究概览
简要总结
Sarcopenia can be easily observed in patients with hemodialysis. However, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. The investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. In 2021, the investigators conducted a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis to confirm the effectiveness. This study is a follow-up study, conducted as a randomized controlled trial.
详细描述
This is a prospective, 1:1 randomized controlled study with 40 patients with hemodialysis who were diagnosed as sarcopenia or frailty in our previous cohort study. Combined intervention will consist of resistance exercise and nutritional supplementation for 12 weeks. The primary outcome of this study is muscle mass and handgrip strength after 12 weeks' intervention. All functional outcomes will be measured at 0, 4, 8 and 12 weeks after intervention. The data will be analysed using the intention-to-treat principle.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hemodialysis
- •Community-dwellers
- •Able to walk with or without assistive devices for more than 100 meters
排除标准
- •A person with cancer disease.
- •People with psychiatric symptoms.
- •A person who has an absorption disorder or has a history of resection of the small intestine or colon
- •Pregnant women
- •A person treated for acute bacterial infections
- •A person who is in a wheelchair due to inconvenience in walking.
研究组 & 干预措施
Improved skeletal muscle function due to protein supplementation and exercise
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
干预措施: exercise and nutritional support (Other)
control
No intervention, but the same measurements as the experimental group are conducted.
结局指标
主要结局
Handgrip strength in Kg using a portable dyanometer
时间窗: 12 weeks
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle every 4 weeks.
Body composition using dual energy x-ray absorptiometry (DXA)
时间窗: 12 weeks
Body composition will be evaluated by dual energy x-ray absorptiometry at start and end of the study.
Body composition using body composition monitor (BCM)
时间窗: 12 weeks
Body composition will be evaluated by bioimpedence analysis using body composition monitor start at and end of the study.
次要结局
- skeletal muscle mass index(SMI) in cm2/m2(12 weeks)
- The total score of Short Physical Performance Battery(SPPB)(12 weeks)
- The second of 5 times Chair Stand Test(12 weeks)
- Glucose pattern using continuous glucose monitoring system(freestyle libre)(12 weeks)