Post COVID-19 ConditionSarcopeniaNCT06211686
The Effectiveness of a Health Promotion Program for Older People With Post-Covid-19 Sarcopenia
A study testing Protein powder and Resistance exercise in people with Post COVID-19 Condition, run by Mahidol University.
Trial summary
The goal of this clinical trial is to investigate the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok and to test the effectiveness of health promotion program for older people with post-COVID-19 Sarcopenia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Protein powder and Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older people with post-COVID-19 sarcopenia aged more than and equal 60 years
- No disabilities
- Able to read, write and communicate Thai langue
- Live in Bangkok
- Moderate post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale
- No soy protein allergy
- Sign inform consent
Who cannot join
- Severe post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale and complicated health problems
- Disabilities
- Unable to read, write and communicate Thai langue
- Soy protein allergy
- CKD 4 and CKD 5
- Deny or withdraw from project
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to investigate the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok and to test the effectiveness of health promotion program for older people with post-COVID-19 Sarcopenia. The main questions it aim to answer are: • How many is the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok? • Can the health promotion program improve muscle mass and muscle strength in older people with post-COVID-19 Sarcopenia ? Participants will be asked eating protein supplement one scoop /day and exercising 2 times/week for 3 months.
- Conditions
- Post COVID-19 Condition
- Being tested
- Protein powder and Resistance exercise
- Keywords
- Sarcopenia, Older people, Health Promotion Program, Post COVID-19
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein powder and Resistance exerciseOther
- Protein powder supplementation 25-30 g/day
- Resistance exercise 2 time/week
| Study group | Role | What they receive |
|---|---|---|
| Protein supplement and Resistance exercise | Experimental | Not described Receives: Other: Protein powder and Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Muscle mass will be measured using BIA and calf circumference in kilograms.
Measured: 3 months
Muscle strength
Muscle strength will be assessed using hand grip strength in kilograms.
Measured: 3 motnhs
Physical fitness
Physical fitness will be measured using the Five Times Sit to Stand Test (FTSST) in second.
Measured: 3 months
Secondary outcomes (1)
Prevalence of sarcopenia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I: Descriptive survey research Phase II: Quasi-experimental research
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Security Office, Thailand
- Responsible party
- Principal investigator, Wanabhorn Tongchom, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211686
- Sponsor's protocol ID
- MURA2023/918
- Other IDs
- 2023/918
- Acronym
- Sarcopenia
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Health Promotion Program for Older People With Post-Covid-19 Sarcopenia
- ClinicalTrials.gov ID
- NCT06211686
- Acronym / sponsor ID
- Sarcopenia / MURA2023/918
- Conditions
- Post COVID-19 Condition
- Keywords
- Sarcopenia, Older people, Health Promotion Program, Post COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Health Security Office, Thailand
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
The goal of this clinical trial is to investigate the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok and to test the effectiveness of health promotion program for older people with post-COVID-19 Sarcopenia. The main questions it aim to answer are: • How many is the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok? • Can the health promotion program improve muscle mass and muscle strength in older people with post-COVID-19 Sarcopenia ? Participants will be asked eating protein supplement one scoop /day and exercising 2 times/week for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I: Descriptive survey research Phase II: Quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| Protein supplement and Resistance exercise | Experimental | Other: Protein powder and Resistance exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older people with post-COVID-19 sarcopenia aged more than and equal 60 years
- No disabilities
- Able to read, write and communicate Thai langue
- Live in Bangkok
- Moderate post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale
Key exclusion criteria (6 listed)
- Severe post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale and complicated health problems
- Disabilities
- Unable to read, write and communicate Thai langue
- Soy protein allergy
- CKD 4 and CKD 5
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 |
|---|---|---|
| Protein powder and Resistance exercise1. Protein powder supplementation 25-30 g/day 2. Resistance exercise 2 time/week | Other | Protein supplement and Resistance exercise |
Primary outcome
Muscle mass
Time frame: 3 months
Muscle mass will be measured using BIA and calf circumference in kilograms.
Muscle strength
Time frame: 3 motnhs
Muscle strength will be assessed using hand grip strength in kilograms.
Physical fitness
Time frame: 3 months
Physical fitness will be measured using the Five Times Sit to Stand Test (FTSST) in second.
1 secondary outcome
Prevalence of sarcopenia
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Protein powder and Resistance exercise in people with Post COVID-19 Condition, run by Mahidol University.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Wanabhorn Tongchom, Doctoral (022012652, wanabhorntc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 3 months). 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 Jan 2024.