The Cardio-Sarcopenia Study

April 19, 2022 updated by: National Heart Centre Singapore
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre Singapore
        • Contact:
        • Principal Investigator:
          • Angela S. Koh, MBBS
        • Sub-Investigator:
          • Louis LY Teo, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • >=21 years of age

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six to twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body mass index (BMI)
Time Frame: Six to Twelve months
To study rates of changes in body mass index in relation to changes in cardio-sarcopenia.
Six to Twelve months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cardiac function as assessed by personalized digital health application.
Time Frame: Six to Twelve month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2051

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/2263

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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