NCT05203406

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
312mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
May 2022Dec 2051

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
28 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2051

Expected
Last Updated

June 5, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

January 10, 2022

Last Update Submit

June 3, 2025

Conditions

Keywords

agingcardiovascularskeletal musclesarcopeniapreventiondigital technology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in body mass index (BMI)

    Six to Twelve months

Other Outcomes (1)

  • Changes in cardiac function as assessed by personalized digital health application.

    Six to Twelve month

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants are recruited through population based studies (SingHealth IRB 2018/3173) who have agreed to be contacted for future studies.

You may qualify if:

  • \>=21 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

Related 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.

    PMID: 31418823BACKGROUND

MeSH Terms

Conditions

Motor ActivitySarcopenia

Condition Hierarchy (Ancestors)

BehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

May 1, 2022

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2051

Last Updated

June 5, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations