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Clinical Trials/NCT04791306
NCT04791306
Completed
N/A

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

Paracelsus Medical University1 site in 1 country46 target enrollmentJuly 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sedentary Behavior
Sponsor
Paracelsus Medical University
Enrollment
46
Locations
1
Primary Endpoint
miRNA expression response to acute all-out exercise (ergometry)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Paracelsus Medical University
Responsible Party
Principal Investigator
Principal Investigator

Prof. Josef Niebauer M.D., Ph.D., MBA

Prim. Univ.Prof.Dr.Dr. Josef Niebauer, MBA

Paracelsus Medical University

Eligibility 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

Outcomes

Primary Outcomes

miRNA expression response to acute all-out exercise (ergometry)

Time Frame: 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

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).

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

Secondary Outcomes

  • blood lipides(Before and after 4 months of exercise intervention)
  • arterial stiffness(Before and after 4 months of exercise intervention)
  • Heart rate(Before and after 4 months of exercise intervention)
  • digital application(4 months of exercise intervention)
  • body composition(Before and after 4 months of exercise intervention)
  • exercise capacity(Before and after 4 months of exercise intervention)
  • body weight(Before and after 4 months of exercise intervention)

Study Sites (1)

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