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EaRneST: Exercise and CiRulating MetabolomicS: A Pilot Randomized Controlled Study

Sponsor
National Heart Centre Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT03617653
Collaborator
Duke-NUS Graduate Medical School (Other)
30
Enrollment
1
Location
2
Arms
9.3
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Brief Summary The purpose of this study is to investigate how circulating metabolites mediate changes in heart function after exercise intervention.

Condition or disease :Cardiovascular function

Intervention/treatment Cardiovascular: Echocardiography Other: Vascular Stiffness Other:

Metabolomics (Blood)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Group A
 N/A

Detailed Description

Detailed Description The purpose of the study is to determine the effect of a structured exercise intervention on mitochondrial fuel metabolism and cardiovascular function. Participants with diastolic dysfunction will undergo a structured exercise intervention.

Group A (intervention) will undergo exercise intervention for three months and Group B (control) will not receive the exercise intervention. At the start of the study and upon completion, all participants will undergo cardiovascular tests to measure cardiovascular function, as well bio-specimen (blood and urine) collection for metabolic profiling.

Study Design Study Type : Randomized controlled trial Estimated Enrollment :40 participants Time Perspective:Prospective Official Title:EaRneST: Exercise and CiRculating MetabolomicS: A Pilot Randomized Controlled Study Study Start Date :July 2018 Estimated Primary Completion Date :Nov 2019 Estimated Study Completion Date : Nov 2019

Groups and Cohorts Group/Cohort :Group A Intervention/treatment Visit 1. Baseline procedures

  1. Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.

Resting electrocardiography will be performed to ascertain sinus rhythm.

  1. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.

  2. Six-minute walk test The Six-Minute Walk Test is a shuttle walk test.

  3. Musculoskeletal Analysis Participants will undergo focused examinations that include measurement of height, weight, body mass index, waist circumference, body composition analysis.

Visit 2 to Visit 13. One time per week exercise intervention for a total of three months

Visit 14: End of three months' procedures.

  1. Cardiovascular measurements Echocardiography Resting electrocardiography will be performed to ascertain sinus rhythm.

  2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.

  3. Six-minute walk test

  4. Musculoskeletal Analysis

Group B Visit 1. Baseline procedures

  1. Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.

Resting electrocardiography will be performed to ascertain sinus rhythm.

  1. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.

  2. Six-minute walk test The Six-Minute Walk Test is a shuttle walk test.

  3. Musculoskeletal Analysis Participants will undergo focused examinations that include measurement of height, weight, body mass index, waist circumference, body composition analysis.

Visit 2: End of three months' procedures.

  1. Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Resting electrocardiogram will be performed to ascertain heart rhythm.

  2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.

  3. Six-minute walk test

  4. Musculoskeletal Analysis Outcome Measures

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
EaRneST: Exercise and CiRulating MetabolomicS: A Pilot Randomized Controlled Study
Actual Study Start Date :
Feb 19, 2019
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Nov 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Group A - Intervention

Baseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis, Exercise intervention from Visit 2 to Visit 13, End of 3 month assessment.

Diagnostic Test: Group A
Refer to detailed study Description
Other Names:
  • six minute walk test
  • exercise intervention

    		•
    Other: Group B- Control

    Baseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis & End of 3 month assessment.

    Diagnostic Test: Group A
    Refer to detailed study Description
    Other Names:
  • six minute walk test
  • exercise intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Metabolmic Profile [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 40 years old and above

    • At least Grade 1 Diastolic Dysfunction

    • Willing and able to give informed consent for participation for the study

    Exclusion Criteria:

    • History of cardiovascular disease

    • History of cancer

    • History of stroke

    • Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension

    • Low blood pressure (systolic blood pressure <90mmHg or diastolic blood pressure <40mmHg)

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • National Heart Centre Singapore
    • Duke-NUS Graduate Medical School

    Investigators

    • Principal Investigator: Su-Mei Angela Koh, MBBS, National Heart Centre Singapore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Heart Centre Singapore
    ClinicalTrials.gov Identifier:
    NCT03617653
    Other Study ID Numbers:
    • 2018/2118
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Apr 19, 2021