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RecruitingNCT05884138Updated Mar 18, 2026

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

An interventional study of exercise and nutritional support in Sarcopenia, sponsored by Chungnam National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Chungnam National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Sarcopenia

Keywords

  • hemodialysis
  • nutrition
  • exercise
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Chungnam National University Hospital is the lead sponsor of 20 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with hemodialysis
  • Community-dwellers
  • Able to walk with or without assistive devices for more than 100 meters

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • No intervention
    control

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

Interventions

  • Otherexercise and nutritional support

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

06

What researchers measure

Primary outcomes

  1. Handgrip strength in Kg using a portable dyanometer

    Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle every 4 weeks.

    Time frame: 12 weeks

  2. Body composition using dual energy x-ray absorptiometry (DXA)

    Body composition will be evaluated by dual energy x-ray absorptiometry at start and end of the study.

    Time frame: 12 weeks

  3. Body composition using body composition monitor (BCM)

    Body composition will be evaluated by bioimpedence analysis using body composition monitor start at and end of the study.

    Time frame: 12 weeks

Secondary outcomes

  1. The total score of Short Physical Performance Battery(SPPB)

    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.

    Time frame: 12 weeks

  2. The second of 5 times Chair Stand Test

    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.

    Time frame: 12 weeks

  3. skeletal muscle mass index(SMI) in cm2/m2

    The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).

    Time frame: 12 weeks

  4. Glucose pattern using continuous glucose monitoring system(freestyle libre)

    Blood glucose is measured using continuous glucose monitoring system(freestyle libre) at start and end of the study.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Chungnam National University Hospital
    Daejeon, South Korea 35015, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05884138
Lead sponsor
Chungnam National University Hospital
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Aug 28, 2023
Primary completion
Dec 31, 2024
Completion
Aug 23, 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Hyon-Seung Yi
Contact
jmpbooks00@gmail.com
82-10-2411-9766
Hyon-Seung Yi
study chair · Chungnam National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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