SarcopeniaNCT04927208
Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis
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 yearsHealthy volunteers can take part
- 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
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jan 2021to 9 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- 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.
About this study
Official title: 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. Here, The investigators aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis.
This is a prospective study with 60 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, 12, and 24 weeks after intervention. The data will be analysed using the intention-to-treat principle.
Read the detailed description
While feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis have been used to measure appendicular skeletal muscle mass. In addition, isokinetic strength will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. The main two axes of treatment of conventional sarcopenia are muscle resistance exercises and protein supplementation including branched chain amino acids. Therefore, it is necessary to confirm the clinical effect by intervention for resistance exercise and nutritional supplementation in patients with hemodialysis.
- Conditions
- Sarcopenia
- Being tested
- exercise and nutritional support
- Medical subject headings
- Sarcopenia
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
Other: Combined exercise and nutrition intervention resistance exercise and nutritional supplementation for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Improved skeletal muscle function due to protein supplementation | Experimental | Experimental: Intervention group Improved skeletal muscle function due to protein supplementation Receives: Other: exercise and nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength in Kg
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.
Measured: 24weeks
Secondary outcomes (3)
The total score of SPPB(Short Physical Performance Battery)
The total score is the sum of 5 times CST score and balance test score and gait speed test score for 4meter.
Measured: 24 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: 24 weeks
skeletal muscle mass index in cm2/m2
The SMI was calculated according to the following formula: skeletal muscle mass (cm 2) / height 2 (m 2).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start27 Jan 2021
- Primary completion1 Apr 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927208
- Sponsor's protocol ID
- CNUH-ED-2021-001
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ju SH, Lee EJ, Sim BC, Nga HT, Lee HY, Tian J, Cho KJ, Park H, Choi DE, Ham YR, Yi HS. Leucine-enriched amino acid supplementation and exercise to prevent sarcopenia in patients on hemodialysis: a single-arm pilot study. Front Nutr. 2023 Apr 28;10:1069651. doi: 10.3389/fnut.2023.1069651. eCollection 2023.
PubMed 37187878
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04927208
- Acronym / sponsor ID
- CNUH-ED-2021-001
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 15 Jun 2021 (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. Here, The investigators aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis.
This is a prospective study with 60 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, 12, and 24 weeks after intervention. The data will be analysed using the intention-to-treat principle.
Detailed description
While feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis have been used to measure appendicular skeletal muscle mass. In addition, isokinetic strength will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. The main two axes of treatment of conventional sarcopenia are muscle resistance exercises and protein supplementation including branched chain amino acids. Therefore, it is necessary to confirm the clinical effect by intervention for resistance exercise and nutritional supplementation in patients with hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improved skeletal muscle function due to protein supplementation | Experimental | Other: exercise and nutritional supportExperimental: Intervention group Improved skeletal muscle function due to protein supplementation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- 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: Combined exercise and nutrition intervention resistance exercise and nutritional supplementation for 12 weeks | Other | Improved skeletal muscle function due to protein supplementation |
Primary outcome
Handgrip strength in Kg
Time frame: 24weeks
Measurement of handle strength using a portable dynamometer to view the function of skeletal muscle.
3 secondary outcomes
The total score of SPPB(Short Physical Performance Battery)
Time frame: 24 weeks
The second of 5 times Chair Stand Test
Time frame: 24 weeks
skeletal muscle mass index in cm2/m2
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 37187878Ju SH, Lee EJ, Sim BC, Nga HT, Lee HY, Tian J, Cho KJ, Park H, Choi DE, Ham YR, Yi HS. Leucine-enriched amino acid supplementation and exercise to prevent sarcopenia in patients on hemodialysis: a single-arm pilot study. Front Nutr. 2023 Apr 28;10:1069651. doi: 10.3389/fnut.2023.1069651. eCollection 2023.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, as of the sponsor's last update on 29 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength in Kg (time frame: 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927208, which also lists 1 linked publication.
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 29 Dec 2021.