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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of a 4 Months Training Intervention on Exercise-induced Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals

Conditions
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Sedentary Behavior

Intervention / Treatment
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* Other: supervised exercise training
* Other: home-based exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br>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<br>* Participates perform once a week for 4 months an in-house supervised endurance and strength training.<br>Other: home-based exercise training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA expression response to acute all-out exercise (ergometry) | expression change of miRNA due to all-out ergometry at baseline | Baseline | 
| Change from baseline miRNA expression at 4 months | 4 months of exercise intervention in healthy previously sedentary participants leads to exercise-induced changes in the cardio protective miRNA expression profiles | after 4 months of exercise intervention | 
| Change from baseline in miRNA expression response to acute all-out exercise (ergometry) at 4 months | 4 months of exercise intervention in healthy previously sedentary participants leads to a change in the acute exercise response (all-out ergometry). | after 4 months of exercise intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate will be measured by graded exercise testing on cycle ergometer. | Before and after 4 months of exercise intervention | 
| blood lipides | blood lipides will be measured before and after intervention | Before and after 4 months of exercise intervention | 
| arterial stiffness | arterial stiffness will be measured before and after intervention | Before and after 4 months of exercise intervention | 
| body composition | body composition will be measured before and after intervention | Before and after 4 months of exercise intervention | 
| exercise capacity | exercise capacity will be measured by graded exercise testing on cycle ergometer. | Before and after 4 months of exercise intervention | 
| body weight | body weight will be measured before and after intervention | Before and after 4 months of exercise intervention | 
| digital application | user feedback and user experience will be evaluated after the intervention | 4 months of exercise intervention |