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NCT Number: NCT04791306

Impact of 4 Months of Exercise 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.

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Key information

Conditions

Sedentary Behavior Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Salzburg, 5020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Exercise training

Other

Participates perform once a week for 4 months an in-house supervised endurance and strength training.

Home-based exercise training

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Paracelsus Medical University

Other

Collaborators

  • Ludwig Boltzmann Institute for Digital Health and Prevention

Registry information

Official study title

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

Acronym: miR-4-heart

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 10, 2021
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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