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Impact of 4 Months of Exercise Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals (miR-4-heart)

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ClinicalTrials.gov Identifier: NCT04791306
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Ludwig Boltzmann Institute for Digital Health and Prevention
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University

Study Description
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Brief Summary:
We aim to analyze the impact of a single acute exercise intervention (ergometry) on the expression pattern of specific heart health related miRNAs in healthy, previously sedentary participants, and how this pattern will be changed after 4 months of increasing the weekly physical activity >150 minutes.

Condition or disease Intervention/treatment Phase
Sedentary Behavior Other: supervised exercise training Other: home-based exercise training Not Applicable

Detailed Description:

Exercise induced changes in heat health related miRNA expression pattern are analyzed in plasma samples collected at rest and immediately after the completion of an all-out ergo spirometry test, conducted during the baseline examination. Additionally participants will perform a pulse wave analysis to evaluate their arterial stiffness, a bioimpedanzanalysis to evaluate their body composition, blood lipids will be measured as well as their exercise capacity.

After the baseline examination, all participants will perform once per week a supervised endurance and strength training at our facility. In addition, the participants will be provided with a digital application for planning and documentation of their home based physical activity. Together with an expert, they plan their weekly physical activities so that they reach 150 min of physical activity each week over a period of 4 months.

After this training/exercise intervention all participants will perform all measurements from the baseline examination again.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of a 4 Months Training Intervention on Exercise-induced Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise Training
All participants should increase their physical activity level to at least 150 min per week, guided with once a week supervised in-house training as well as an application for planning and documentation for home-based physical activity
 Other: supervised exercise training
Participates perform once a week for 4 months an in-house supervised endurance and strength training.

Other: home-based exercise training
Participants are provided with an application for planning and documentation of their physical activity, together with an expert participants plan their physical activities for their home-based training to reach at least 150 min physical activity per week.


Outcome Measures
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Primary Outcome Measures :
  1. miRNA expression response to acute all-out exercise (ergometry) [ Time Frame: Baseline ]
    expression change of miRNA due to all-out ergometry at baseline

  2. Change from baseline miRNA expression at 4 months [ Time Frame: after 4 months of exercise intervention ]
    4 months of exercise intervention in healthy previously sedentary participants leads to exercise-induced changes in the cardio protective miRNA expression profiles

  3. Change from baseline in miRNA expression response to acute all-out exercise (ergometry) at 4 months [ Time Frame: after 4 months of exercise intervention ]
    4 months of exercise intervention in healthy previously sedentary participants leads to a change in the acute exercise response (all-out ergometry).


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: Before and after 4 months of exercise intervention ]
    Heart rate will be measured by graded exercise testing on cycle ergometer.

  2. blood lipides [ Time Frame: Before and after 4 months of exercise intervention ]
    blood lipides will be measured before and after intervention

  3. arterial stiffness [ Time Frame: Before and after 4 months of exercise intervention ]
    arterial stiffness will be measured before and after intervention

  4. body composition [ Time Frame: Before and after 4 months of exercise intervention ]
    body composition will be measured before and after intervention

  5. exercise capacity [ Time Frame: Before and after 4 months of exercise intervention ]
    exercise capacity will be measured by graded exercise testing on cycle ergometer.

  6. body weight [ Time Frame: Before and after 4 months of exercise intervention ]
    body weight will be measured before and after intervention

  7. digital application [ Time Frame: 4 months of exercise intervention ]
    user feedback and user experience will be evaluated after the intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • <150min physical activity per week
  • >18 years of age
  • male and female
  • signed inform consents

Exclusion Criteria:

  • acute or chronic cardiovascular diseases, exempt arterial hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg in untreated and medical treated subjects)
  • acute or chronic lung disease
  • Alcohol (>30g/day) or drug abuse
  • Adipositas grad 2 (BMI >35kg/m²)
  • Orthopedic limitations to exercise capacity
  • pregnant or breast feeding women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791306


Contacts
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Contact: Prof. Josef Niebauer, MD PhD MBA +43(0) 5 7255 ext 23200 j.niebauer@salk.at
Contact: Barbara Mayr, PhD +43(0) 5 7255 ext 57080 ba.mayr@salk.at

Locations
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Austria
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Recruiting
Salzburg, Austria, 5020
Contact: Prof. Josef Niebauer, MD, PhD, MBA    00436624482 ext 4270    j.niebauer@salk.at   
Contact: Barbara Mayr, PhD    +43(0) 5 7255 ext 57080    ba.mayr@salk.at   
Sponsors and Collaborators
Paracelsus Medical University
Ludwig Boltzmann Institute for Digital Health and Prevention
Investigators
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Principal Investigator: Prof. Josef Niebauer, MD PhD MBA Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
More Information
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Responsible Party: Prof. Josef Niebauer M.D., Ph.D., MBA, Prim. Univ.Prof.Dr.Dr. Josef Niebauer, MBA, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT04791306    
Other Study ID Numbers: UISM-13
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No