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临床试验/NCT04927208
NCT04927208已完成不适用

Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

Chungnam National University Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Handgrip strength in Kg

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. Here, The investigators aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis.

This is a prospective study with 60 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, 12, and 24 weeks after intervention. The data will be analysed using the intention-to-treat principle.

详细描述

While feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis have been used to measure appendicular skeletal muscle mass. In addition, isokinetic strength will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. The main two axes of treatment of conventional sarcopenia are muscle resistance exercises and protein supplementation including branched chain amino acids. Therefore, it is necessary to confirm the clinical effect by intervention for resistance exercise and nutritional supplementation in patients with hemodialysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

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.

结局指标

主要结局

Handgrip strength in Kg

时间窗: 24weeks

Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.

次要结局

  • The total score of SPPB(Short Physical Performance Battery)(24 weeks)
  • The second of 5 times Chair Stand Test(24 weeks)
  • skeletal muscle mass index in cm2/m2(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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