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A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients
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.
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.
Age
20 - 80 years
Sex
ALL
Healthy Volunteers
No
Chungnam National University Hospital
Daejeon, South Korea, South Korea
Start Date
August 28, 2023
Primary Completion Date
December 31, 2024
Completion Date
August 23, 2026
Last Updated
March 18, 2026
40
ESTIMATED participants
exercise and nutritional support
OTHER
Lead Sponsor
Chungnam National University Hospital
NCT06950125
NCT07412379
Data Source & Attribution
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