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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Improved skeletal muscle function due to protein supplementation and exercise

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

Group Type EXPERIMENTAL

exercise and nutritional support

Intervention Type OTHER

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

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise and nutritional support

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No