Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03617653 |
| Other study ID # |
2018/2118 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 19, 2019 |
| Est. completion date |
November 30, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
National Heart Centre Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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)
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.
2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.
3. Six-minute walk test The Six-Minute Walk Test is a shuttle walk test.
4. 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.
2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.
3. Six-minute walk test The Six-Minute Walk Test is a shuttle walk test.
4. 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
