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

Chungnam National University Hospital

Status: Enrolling

Conditions: Sarcopenia

Treatments: Other: exercise and nutritional support

Study type: Interventional

Funder types: Other

Identifiers

NCT05884138

CNUH-ED-2023-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Improved skeletal muscle function due to protein supplementation and exercise

Experimental group

Description:

resistance exercise and protein supplementation including branched chain amino acids for 12 weeks

Treatment:

Other: exercise and nutritional support

control

No Intervention group

Description:

No intervention, but the same measurements as the experimental group are conducted.