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NCT Number: NCT05884138

Effect of Essential Aminoacid Supplementation and Exercise on 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.

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Key information

Conditions

Sarcopenia Atrophy Behavior Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungnam National University Hospital

Daejeon, South Korea, 35015

Location status: Recruiting

Location contact

Hyon-Seung Yi

CONTACT

[email protected]

+82-10-2411-9766

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exercise and nutritional support

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyon-Seung Yi

CONTACT

[email protected]

82-10-2411-9766

Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 1, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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