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

Cardiovascular Disease Other Clinical Trial

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

Status Completed

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)

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cardiovascular Disease Other
• Cardiovascular Diseases

• NCT number: NCT03617653
• Study type: Interventional
• Source: National Heart Centre Singapore
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Completion date: November 30, 2019