SarcopeniaNCT05884138
Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients
A study testing exercise and nutritional support in people with Sarcopenia, run by Chungnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- exercise and nutritional support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2023to 23 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hemodialysis
- Community-dwellers
- Able to walk with or without assistive devices for more than 100 meters
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, South Korea, 35015
Hyon-Seung Yi, +82-10-2411-9766, jmpbooks00@gmail.com
About this study
Official 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
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.
- Conditions
- Sarcopenia
- Being tested
- exercise and nutritional support
- Keywords
- hemodialysis, nutrition, exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and nutritional supportOther
resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Improved skeletal muscle function due to protein supplementation and exercise | Experimental | resistance exercise and protein supplementation including branched chain amino acids for 12 weeks Receives: Other: exercise and nutritional support |
| control | No intervention | No intervention, but the same measurements as the experimental group are conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start28 Aug 2023
- Primary completion31 Dec 2024
- Study completion23 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyon-Seung Yi, Study chair, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884138
- Sponsor's protocol ID
- CNUH-ED-2023-001
- Status last verified
- Mar 2026
- First submitted
- 18 May 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05884138
- Acronym / sponsor ID
- CNUH-ED-2023-001
- Conditions
- Sarcopenia
- Keywords
- hemodialysis, nutrition, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 23 Aug 2026 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improved skeletal muscle function due to protein supplementation and exercise | Experimental | Other: exercise and nutritional supportresistance exercise and protein supplementation including branched chain amino acids for 12 weeks |
| control | No intervention | –No intervention, but the same measurements as the experimental group are conducted. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hemodialysis
- Community-dwellers
- Able to walk with or without assistive devices for more than 100 meters
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and nutritional supportresistance exercise and protein supplementation including branched chain amino acids for 12 weeks | Other | Improved skeletal muscle function due to protein supplementation and exercise |
Primary outcome
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.
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.
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.
4 secondary outcomes
The total score of Short Physical Performance Battery(SPPB)
Time frame: 12 weeks
The second of 5 times Chair Stand Test
Time frame: 12 weeks
skeletal muscle mass index(SMI) in cm2/m2
Time frame: 12 weeks
Glucose pattern using continuous glucose monitoring system(freestyle libre)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyon-Seung Yi study chair
Chungnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and nutritional support in people with Sarcopenia, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyon-Seung Yi (82-10-2411-9766, jmpbooks00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength in Kg using a portable dyanometer (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.