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

March 17, 2026 updated by: Chungnam National University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • South Korea
      • Daejeon, South Korea, South Korea, 35015
        • Recruiting
        • Chungnam National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Improved skeletal muscle function due to protein supplementation and exercise
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
Other: exercise and nutritional support
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
No Intervention: control
No intervention, but the same measurements as the experimental group are conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength in Kg using a portable dyanometer
Time Frame: 12 weeks
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle every 4 weeks.
12 weeks
Body composition using dual energy x-ray absorptiometry (DXA)
Time Frame: 12 weeks
Body composition will be evaluated by dual energy x-ray absorptiometry at start and end of the study.
12 weeks
Body composition using body composition monitor (BCM)
Time Frame: 12 weeks
Body composition will be evaluated by bioimpedence analysis using body composition monitor start at and end of the study.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total score of Short Physical Performance Battery(SPPB)
Time Frame: 12 weeks
The total score is the sum of 5 times Chair Stand Test(CST) score and balance test score and gait speed test score for 4meter.
12 weeks
The second of 5 times Chair Stand Test
Time Frame: 12 weeks
Pre test, participants fold their arms across their chest and try to stand up once from a chair. And Measures the time required to perform five rises from a chair to an upright position as fast as possible without the use of the arms.
12 weeks
skeletal muscle mass index(SMI) in cm2/m2
Time Frame: 12 weeks
The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).
12 weeks
Glucose pattern using continuous glucose monitoring system(freestyle libre)
Time Frame: 12 weeks
Blood glucose is measured using continuous glucose monitoring system(freestyle libre) at start and end of the study.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungnam National University Hospital

Investigators

  • Study Chair: Hyon-Seung Yi, Chungnam National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

August 23, 2026

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUH-ED-2023-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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