Essential amino acid supplements plus resistance exercise to improve muscle function in people on hemodialysis

A Randomized Controlled Trial to Analyze the Effects of Essential Aminoacid Supplementation and Exercise on the Improvement of Skeletal Muscle Function in Hemodialysis Patients

This project will test whether taking essential amino acid supplements together with a 12-week resistance exercise program can increase muscle size and handgrip strength in people on hemodialysis who have sarcopenia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Chungnam National University Hospital (other)
• Locations: 1 site (Daejeon, South Korea)
• Trial ID: NCT05884138 on ClinicalTrials.gov

What this trial studies

This is a prospective, 1:1 randomized controlled trial enrolling 40 hemodialysis patients previously diagnosed with sarcopenia or frailty. Participants will receive a combined intervention of supervised resistance exercise and essential amino acid nutritional supplementation for 12 weeks, with outcomes measured at baseline and at 4, 8, and 12 weeks. The primary outcomes are change in muscle mass and handgrip strength at 12 weeks, and the analysis will follow the intention-to-treat principle. Functional measures and adverse events will also be recorded throughout the intervention period.

Who should consider this trial

Good fit: Adults on maintenance hemodialysis who were diagnosed with sarcopenia or frailty in the prior cohort, live in the community, and can walk at least 100 meters with or without an aid are ideal candidates.

Not a fit: Patients with active cancer, significant psychiatric illness, recent acute bacterial infection, pregnancy, major small intestine or colon resection, or those who are wheelchair-bound and unable to walk 100 meters are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combined exercise and amino acid supplement program could increase muscle mass and strength, improving mobility and daily function for people on hemodialysis with sarcopenia.

How similar studies have performed: The investigators reported a 2021 pilot suggesting benefit, and prior trials in older adults and some dialysis cohorts have shown that combined resistance exercise and protein/amino acid supplements can improve muscle mass and strength, but large randomized trials in hemodialysis patients are still limited.

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.

Where this trial is running

Daejeon, South Korea

• Chungnam National University Hospital — Daejeon, South Korea, South Korea (RECRUITING)

Study contacts

• Study coordinator: Hyon-Seung Yi

Conditions: Sarcopenia, hemodialysis, nutrition, exercise