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

Not Applicable

Completed

• Conditions: Sedentary Behavior
• Interventions: Other: supervised exercise training; Other: home-based exercise training

• Registration Number: NCT04791306
• Lead Sponsor: Paracelsus Medical University

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.

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 Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-10
• Study Start: 2021-07-01
• Primary Completion: 2023-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Training	supervised 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
Exercise Training	home-based 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

Primary Outcome Measures

Name	Time	Method
miRNA expression response to acute all-out exercise (ergometry)	Baseline	expression change of miRNA due to all-out ergometry at baseline
Change from baseline in miRNA expression response to acute all-out exercise (ergometry) at 4 months	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).
Change from baseline miRNA expression at 4 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University; 🇦🇹 Salzburg, Austria