Cardiac AgeingNCT05203406
The Cardio-Sarcopenia Study
An observational study of Cardiac Ageing and Physical Activity, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
The use of surrogate markers such as body mass index (BMI) as a target outcome of physical activity may not be appropriate in older adults who are at risk of muscle sarcopenia. In the presence of sarcopenia, reductions in body weight may lead to lower BMI values. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Ageing, Physical Activity, Older Adults
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2022to 31 Dec 2051
- Phase
- Observational
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are recruited through population based studies (SingHealth IRB 2018/3173) who have agreed to be contacted for future studies.
Who may be able to join
- >=21 years of age
Who cannot join
- Unable to provide written informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National Heart Centre Singapore
Singapore, Singapore, 169609
About this study
The use of surrogate markers such as body mass index (BMI) as a target outcome of physical activity may not be appropriate in older adults who are at risk of muscle sarcopenia. In the presence of sarcopenia, reductions in body weight may lead to lower BMI values. We have previously found deleterious changes in cardiac structure and function among sarcopenic older adults, raising a possible biological syndrome of 'cardio-sarcopenia'. In this study, we will investigate the impact of physical activity on temporal changes in cardiac and skeletal muscle , and BMI, over six- to twelve month period, on older adults with this syndrome. By targeting the cardio-sarcopenic phenotype as a modifiable risk factor that may be altered by physical activity, the results will provide new knowledge into retarding deleterious consequences of cardiovascular ageing. This new target challenges the paradigm of using BMI as an anthropometric marker in health prevention. If proven, this will dramatically change primary prevention targets among older adults, justifying the use of cardio-sarcopenia as a rational anthropometric target.
Read the detailed description
This study builds upon our group's work where we characterized cardiovascular and skeletal muscle structure and function of community-based older adults. In this proposal, we will identify n=100 participants with cardio-sarcopenia phenotype. Comparing between participants with baseline low versus high levels of physical activity, we will investigate temporal changes in their cardiovascular, skeletal muscle, biomarkers and BMI data, over a six- to twelve month period. Physical activity will include subjective self-reported physical activities and objective measures of aerobic capacity. Their physical activity levels will be verified bi-monthly via physical activity and cardiac health application that measures these markers. Pertinent fluctuations in diet, lifestyle, risk factors and biomarkers will also be recorded.
- Conditions
- Cardiac Ageing, Physical Activity, Older Adults, Sarcopenia
- Keywords
- aging, cardiovascular, skeletal muscle, sarcopenia, prevention, digital technology
- Medical subject headings
- Motor Activity, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardio-sarcopenia
To compare differences in skeletal muscle (structure and function) and CV imaging markers, between older adults with low versus high physical activity levels, over time, at baseline and at six- to twelve months
Measured: Six to twelve months
Secondary outcomes (1)
Changes in body mass index (BMI)
To study rates of changes in body mass index in relation to changes in cardio-sarcopenia.
Measured: Six to Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2051 (estimated)
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 Cardiac AgeingStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203406
- Sponsor's protocol ID
- 2021/2263
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keng BMH, Gao F, Teo LLY, Lim WS, Tan RS, Ruan W, Ewe SH, Koh WP, Koh AS. Associations between Skeletal Muscle and Myocardium in Aging: A Syndrome of "Cardio-Sarcopenia"? J Am Geriatr Soc. 2019 Dec;67(12):2568-2573. doi: 10.1111/jgs.16132. Epub 2019 Aug 16.
PubMed 31418823
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardio-Sarcopenia Study
- ClinicalTrials.gov ID
- NCT05203406
- Acronym / sponsor ID
- 2021/2263
- Conditions
- Cardiac Ageing, Physical Activity, Older Adults, Sarcopenia
- Keywords
- aging, cardiovascular, skeletal muscle, sarcopenia, prevention, digital technology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2051 (estimated)
- First posted
- 24 Jan 2022 (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 use of surrogate markers such as body mass index (BMI) as a target outcome of physical activity may not be appropriate in older adults who are at risk of muscle sarcopenia. In the presence of sarcopenia, reductions in body weight may lead to lower BMI values. We have previously found deleterious changes in cardiac structure and function among sarcopenic older adults, raising a possible biological syndrome of 'cardio-sarcopenia'. In this study, we will investigate the impact of physical activity on temporal changes in cardiac and skeletal muscle , and BMI, over six- to twelve month period, on older adults with this syndrome. By targeting the cardio-sarcopenic phenotype as a modifiable risk factor that may be altered by physical activity, the results will provide new knowledge into retarding deleterious consequences of cardiovascular ageing. This new target challenges the paradigm of using BMI as an anthropometric marker in health prevention. If proven, this will dramatically change primary prevention targets among older adults, justifying the use of cardio-sarcopenia as a rational anthropometric target.
Detailed description
This study builds upon our group's work where we characterized cardiovascular and skeletal muscle structure and function of community-based older adults. In this proposal, we will identify n=100 participants with cardio-sarcopenia phenotype. Comparing between participants with baseline low versus high levels of physical activity, we will investigate temporal changes in their cardiovascular, skeletal muscle, biomarkers and BMI data, over a six- to twelve month period. Physical activity will include subjective self-reported physical activities and objective measures of aerobic capacity. Their physical activity levels will be verified bi-monthly via physical activity and cardiac health application that measures these markers. Pertinent fluctuations in diet, lifestyle, risk factors and biomarkers will also be recorded.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited through population based studies (SingHealth IRB 2018/3173) who have agreed to be contacted for future studies.
Key inclusion criteria (1 listed)
- >=21 years of age
Key exclusion criteria (1 listed)
- Unable to provide written informed consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in cardio-sarcopenia
Time frame: Six to twelve months
To compare differences in skeletal muscle (structure and function) and CV imaging markers, between older adults with low versus high physical activity levels, over time, at baseline and at six- to twelve months
1 secondary outcome
Changes in body mass index (BMI)
Time frame: Six to Twelve months
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 5 Jun 2025.
- Background: PubMed 31418823Keng BMH, Gao F, Teo LLY, Lim WS, Tan RS, Ruan W, Ewe SH, Koh WP, Koh AS. Associations between Skeletal Muscle and Myocardium in Aging: A Syndrome of "Cardio-Sarcopenia"? J Am Geriatr Soc. 2019 Dec;67(12):2568-2573. doi: 10.1111/jgs.16132. Epub 2019 Aug 16.
- 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.
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?
An observational study of Cardiac Ageing and Physical Activity, run by National Heart Centre Singapore at 1 site in Singapore.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. 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 Singapore. 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?
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?
Changes in cardio-sarcopenia (time frame: Six to twelve months). 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 NCT05203406, 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 5 Jun 2025.