The Cardio-Sarcopenia Study

Physical Activity Clinical Trial

Official title:

The Cardio-Sarcopenia Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203406
• Other study ID #: 2021/2263
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2051

Study information

• Verified date: March 2023
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2051
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• >=21 years of age

Exclusion Criteria:

• Unable to provide written informed consent to participate in the study.

Related Conditions & MeSH terms

• Cardiac Ageing
• Older Adults
• Physical Activity
• Sarcopenia

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Centre Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in cardiac function as assessed by personalized digital health application.	To test feasibility and utility of using cardiac health application to input markers of physical activity, deriving automated feedback about cardiac function.	Six to Twelve month
Primary	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	Six to twelve months
Secondary	Changes in body mass index (BMI)	To study rates of changes in body mass index in relation to changes in cardio-sarcopenia.	Six to Twelve months