Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exercise and nutritional support.
- Who it may be relevant to
- Registry conditions: Sarcopenia. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients
Overview
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.
Detailed description
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.
Interventions
- Other exercise and nutritional support
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
Primary outcome measures
- Handgrip strength in Kg using a portable dyanometer [Time frame: 12 weeks]
- Body composition using dual energy x-ray absorptiometry (DXA) [Time frame: 12 weeks]
- Body composition using body composition monitor (BCM) [Time frame: 12 weeks]
Secondary outcome measures (4)
- The total score of Short Physical Performance Battery(SPPB) [Time frame: 12 weeks]
- The second of 5 times Chair Stand Test [Time frame: 12 weeks]
- skeletal muscle mass index(SMI) in cm2/m2 [Time frame: 12 weeks]
- Glucose pattern using continuous glucose monitoring system(freestyle libre) [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Patients with hemodialysis
- Community-dwellers
- Able to walk with or without assistive devices for more than 100 meters
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Chungnam National University Hospital — Daejeon
Identifiers
NCT: NCT05884138 · CNUH-ED-2023-001