Clinical trial NCT05203406: The Cardio-Sarcopenia Study
Official title: The Cardio-Sarcopenia Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Ageing
Physical Activity
Older Adults
Sarcopenia
Keywords: aging
cardiovascular
skeletal muscle
sarcopenia
prevention
digital technology
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants are recruited through population based studies (SingHealth IRB 2018/3173) who have agreed to be contacted for future studies.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* \>=21 years of age

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in cardio-sarcopenia
timeFrame: Six to twelve months
Secondary outcomes:
measure: Changes in body mass index (BMI)
timeFrame: Six to Twelve months
Other outcomes:
measure: Changes in cardiac function as assessed by personalized digital health application.
timeFrame: Six to Twelve month
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
References:
citation: 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.