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

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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Behavior
• Intervention / Treatment: Other: supervised exercise training; Other: home-based exercise training

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Paracelsus Medical University
• Collaborators: Ludwig Boltzmann Institute for Digital Health and Prevention
• Investigators: Principal Investigator: Prof. Josef Niebauer, MD PhD MBA, Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UISM-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No