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Exercise to Slow Cardiovascular Ageing Progression

Sponsor
National Heart Centre Singapore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05775484
Collaborator
(none)
450
Enrollment
1
Location
344
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In ageing, deleterious alterations in cardiovascular (CV) structure and function increase risks of ageing-related cardiovascular disease (CVD). We found that these CV alterations were associated with circulating serum metabolites, suggesting a metabolic basis to CV ageing. We hypothesize that modification of these metabolites by intervention, such as exercise, may retard CV alterations and reduce CVD in ageing.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants from each stratum will be randomized to receive either an exercise program intervention or no exercise. At the start and end of study, participants will undergo cardiovascular imaging and metabolic profiling. We will determine if exercise can reverse high-risk metabolic profiles and improve cardiovascular structure and function.

    Without clear mechanisms to explain cardiovascular ageing nor interventions known to retard cardiovascular ageing, our approach will provide much needed translational evidence to incorporate targeted interventions aimed at reducing cardiovascular disease risk in older populations.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exercise to Slow Cardiovascular Ageing Progression
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2051

    Arms and Interventions

    Arm Intervention/Treatment
    A

    Cardiovascular measurements Non-invasive brachial blood pressure machine Echocardiography Bio-specimen collection Six-minute walk test Musculoskeletal Analysis Cardiopulmonary exercise test
    B

    Cardiovascular measurements Non-invasive brachial blood pressure machine Echocardiography Bio-specimen collection Six-minute walk test Musculoskeletal Analysis
    C

    Cardiovascular measurements Non-invasive brachial blood pressure machine Echocardiography Bio-specimen collection Six-minute walk test Musculoskeletal Analysis
    D

    Cardiovascular measurements Non-invasive brachial blood pressure machine Echocardiography Bio-specimen collection Six-minute walk test (may require separate day visit to complete) Musculoskeletal Analysis Questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Metabolite profiles [12 Months]

      To measure changes in serum metabolite levels among participants pre and post exercise intervention.

    2. Cardiovascular structure and function [12 Months]

      To measure changes in CV structure and function (diastolic function, arterial stiffness) among participants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age >=21 years old

    • Outdoor ambulant

    Exclusion Criteria:

    • Wheelchair or bed-bound

    • Dementia

    • Residing in sheltered or nursing home

    • Cancer

    • Participation in ongoing clinical trials that involve interventional drugs or devices

    • Aneurysms

    • Acute infections (in the last six months)

    • Uncontrolled thyrotoxicosis

    • Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise

    • Uncontrolled asthma or chronic lung disease

    • Restrictive lung disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Heart Centre Singapore Singapore Singapore 169609

    Sponsors and Collaborators

    • National Heart Centre Singapore

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Heart Centre Singapore
    ClinicalTrials.gov Identifier:
    NCT05775484
    Other Study ID Numbers:
    • 2022/2667
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 20, 2023