EaRneST: Exercise and CiRulating MetabolomicS: A Pilot Randomized Controlled Study
Condition: Cardiovascular Disease Other
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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)
    

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.

        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
    

Intervention name(s): Group A
Intervention type(s): Diagnostic Test
Intervention description(s): Refer to detailed study Description
Other intervention name(s): six minute walk test; exercise intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other