SarcopeniaNCT05809219
the Effect of Exercise and Oral Supplement Intervention in Sarcopenia Markers in Hemodialysis Patients
A study testing 1 hour combined intervention ( Exercise and nutrition), 3 hours combined intervention ( Exercise and nutrition) and Nutrition intervention in people with Sarcopenia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Objective: To assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients. Study Design: 24-weeks Randomized Control Trial (RCT), includes 12-wk intervention period and 12-week follow up period. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- 1 hour combined intervention ( Exercise and nutrition), 3 hours combined intervention ( Exercise and nutrition) and Nutrition intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jul 2023to 29 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis treatment longer than 3 months
- Hemodialysis treatment 3 times treatment per weeks
- Kt/V≥1.2 or URR≥65%
- Taking foods by oral
- Meeting the criteria of sarcopenia.
Who cannot join
- Soy allergy
- Amputation
- Significantly edema
- Receiving palliative care
- Severe angina
- Unstable arrhythmias
Show all 17Show fewer
- Severe infection
- Heart failure (class 4 of New York Heart Association scale)
- Central venous catheter or femoral arteriovenous fistula
- Pacemaker
- Pregnancy
- Severe paleness
- Severe difficulty breathing
- Chest pain
- Hospitalization 3 months before recruited in this study
- Oral supplement intolerance diagnosed by the doctor or dietitian
- Bone injury/nerve damage/cognition impairment affecting physical activity intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Post-exercise Oral Nutritional Supplement Intake Timing on Sarcopenia Indicators in Hemodialysis Patients
Objective: To assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients.
Study Design: 24-weeks Randomized Control Trial (RCT), includes 12-wk intervention period and 12-week follow up period.
Read more
Setting \& Participants: Maintenance hemodialysis patients who were older than 20 years old meet sarcopenia diagnosis criteria.
Intervention: Group A: During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement in 1 to 2 hours after exercise program. Group B: Participants have the same exercise program and oral supplement as Group A. However, they take oral supplement in 2.5-4 hours after exercise program. Group C: Participants only take oral supplement. Control group: Participants maintain usual diet and physical activity without any intervention.
- Conditions
- Sarcopenia
- Being tested
- 1 hour combined intervention ( Exercise and nutrition), 3 hours combined intervention ( Exercise and nutrition), Nutrition intervention
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 hour combined intervention ( Exercise and nutrition)Other
Subjects take oral supplement after exercise in the time period between 1-2 hours. They will take oral supplement during hemodialysis treatment.
3 hours combined intervention ( Exercise and nutrition)Other
All procedures between "1 hour combined intervention" and "3 hours combined intervention" are the same. The only one different is the time interval between exercise and nutrition. In this arm, the time interval of exercise and nutrition is 2.5 to 4 hours. When we recruiting subjects, all interventions will be clearly introduced to them, including the same and the different parts among them.
Nutrition interventionDietary supplement
Subjects only take oral supplement during hemodialysis treatment. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention".
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants maintain usual diet and physical activity without any intervention |
| 1 hour combined intervention ( Exercise and nutrition) | Experimental | During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement (103 kcal and 8.4 g of protein) in 1 to 2 hours after exercise program. Receives: Other: 1 hour combined intervention ( Exercise and nutrition) |
| 3 hours combined intervention ( Exercise and nutrition) | Experimental | The only one different between "1 hour combined intervention" and this intervention is the time interval between exercise and nutrition. The time interval of "1 hour combined intervention" is 1 to 2 hour, and this intervention is 2.5-4 hours. Other procedure is totally the same. Receives: Other: 3 hours combined intervention ( Exercise and nutrition) |
| Nutrition intervention | Experimental | Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention". Receives: Dietary Supplement: Nutrition intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Measured: Change from baseline appendicular skeletal muscle mass at 3 months
Appendicular skeletal muscle mass
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Measured: Change from baseline appendicular skeletal muscle mass at 6 months
Muscle strength
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Measured: Change from baseline muscle strength at 3 months
Muscle strength
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Measured: Change from baseline muscle strength at 6 months
Physical performance
Measuring whether the of 6-meter walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Measured: Change from baseline physical performance at 3 months
Physical performance
Measuring whether the of 6-metre walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Measured: Change from baseline physical performance at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start10 Jul 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Yu Wu, China Medical University Hospital
- Investigators
- PEIYU WU, Principal investigator, Project Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809219
- Sponsor's protocol ID
- NSTC 112-2320-B-039-008
- Status last verified
- Sep 2023
- First submitted
- 18 Mar 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the records approved by IRB, the individual participant data of all participants should be protected.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Post-exercise Oral Nutritional Supplement Intake Timing on Sarcopenia Indicators in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05809219
- Acronym / sponsor ID
- NSTC 112-2320-B-039-008
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 12 Apr 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.
Objective: To assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients.
Study Design: 24-weeks Randomized Control Trial (RCT), includes 12-wk intervention period and 12-week follow up period.
Setting \& Participants: Maintenance hemodialysis patients who were older than 20 years old meet sarcopenia diagnosis criteria.
Intervention: Group A: During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement in 1 to 2 hours after exercise program. Group B: Participants have the same exercise program and oral supplement as Group A. However, they take oral supplement in 2.5-4 hours after exercise program. Group C: Participants only take oral supplement. Control group: Participants maintain usual diet and physical activity without any intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants maintain usual diet and physical activity without any intervention |
| 1 hour combined intervention ( Exercise and nutrition) | Experimental | Other: 1 hour combined intervention ( Exercise and nutrition)During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement (103 kcal and 8.4 g of protein) in 1 to 2 hours after exercise program. |
| 3 hours combined intervention ( Exercise and nutrition) | Experimental | Other: 3 hours combined intervention ( Exercise and nutrition)The only one different between "1 hour combined intervention" and this intervention is the time interval between exercise and nutrition. The time interval of "1 hour combined intervention" is 1 to 2 hour, and this intervention is 2.5-4 hours. Other procedure is totally the same. |
| Nutrition intervention | Experimental | Dietary Supplement: Nutrition interventionParticipants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention". |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemodialysis treatment longer than 3 months
- Hemodialysis treatment 3 times treatment per weeks
- Kt/V≥1.2 or URR≥65%
- Taking foods by oral
- Meeting the criteria of sarcopenia.
Key exclusion criteria (17 listed)
- Soy allergy
- Amputation
- Significantly edema
- Receiving palliative care
- Severe angina
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 |
|---|---|---|
| 1 hour combined intervention ( Exercise and nutrition)Subjects take oral supplement after exercise in the time period between 1-2 hours. They will take oral supplement during hemodialysis treatment. | Other | 1 hour combined intervention ( Exercise and nutrition) |
| 3 hours combined intervention ( Exercise and nutrition)All procedures between "1 hour combined intervention" and "3 hours combined intervention" are the same. The only one different is the time interval between exercise and nutrition. In this arm, the time interval of exercise and nutrition is 2.5 to 4 hours. When we recruiting subjects, all interventions will be clearly introduced to them, including the same and the different parts among them. | Other | 3 hours combined intervention ( Exercise and nutrition) |
| Nutrition interventionSubjects only take oral supplement during hemodialysis treatment. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention". | Dietary supplement | Nutrition intervention |
Primary outcome
Appendicular skeletal muscle mass
Time frame: Change from baseline appendicular skeletal muscle mass at 3 months
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Appendicular skeletal muscle mass
Time frame: Change from baseline appendicular skeletal muscle mass at 6 months
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Muscle strength
Time frame: Change from baseline muscle strength at 3 months
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Muscle strength
Time frame: Change from baseline muscle strength at 6 months
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Physical performance
Time frame: Change from baseline physical performance at 3 months
Measuring whether the of 6-meter walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Physical performance
Time frame: Change from baseline physical performance at 6 months
Measuring whether the of 6-metre walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No. According to the records approved by IRB, the individual participant data of all participants should be protected.
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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. This study is not recruiting at the moment.
PEIYU WU principal investigator
Project Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 hour combined intervention ( Exercise and nutrition), 3 hours combined intervention ( Exercise and nutrition) and Nutrition intervention in people with Sarcopenia, run by China Medical University Hospital at 1 site in Taiwan.
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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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 Taiwan. 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?
Results are not available in the source record.
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?
Appendicular skeletal muscle mass (time frame: Change from baseline appendicular skeletal muscle mass at 3 months). The study lists 6 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 22 Sep 2023.