NCT05884138

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2023Aug 2026

First Submitted

Initial submission to the registry

May 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

May 18, 2023

Last Update Submit

March 17, 2026

Conditions

Sarcopenia

Keywords

hemodialysisnutritionexercise

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 weeks

  • 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.

    12 weeks

  • 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.

    12 weeks

Secondary Outcomes (4)

  • The total score of Short Physical Performance Battery(SPPB)

    12 weeks

  • The second of 5 times Chair Stand Test

    12 weeks

  • skeletal muscle mass index(SMI) in cm2/m2

    12 weeks

  • Glucose pattern using continuous glucose monitoring system(freestyle libre)

    12 weeks

Study Arms (2)

Improved skeletal muscle function due to protein supplementation and exercise

EXPERIMENTAL

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

Other: exercise and nutritional support

control

NO INTERVENTION

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

Interventions

exercise and nutritional supportOTHER

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

Improved skeletal muscle function due to protein supplementation and exercise

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea, 35015, South Korea

RECRUITING

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

ExerciseNutritional Support

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutrition TherapyTherapeutics

Study Officials

  • Hyon-Seung Yi

    Chungnam National University Hospital

    STUDY CHAIR

Central Study Contacts

Hyon-Seung Yi

CONTACT

82-10-2411-9766jmpbooks00@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2023

First Posted

June 1, 2023

Study Start

August 28, 2023

Primary Completion

December 31, 2024

Study Completion (Estimated)

August 23, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)