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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04791306
Acronym
miR-4-heart
Enrollment
46
Registered
2021-03-10
Start date
2021-07-01
Completion date
2024-03-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedentary Behavior

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.

Interventions

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

Sponsors

Ludwig Boltzmann Institute for Digital Health and Prevention
CollaboratorOTHER
Paracelsus Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
miRNA expression response to acute all-out exercise (ergometry)Baselineexpression change of miRNA due to all-out ergometry at baseline
Change from baseline miRNA expression at 4 monthsafter 4 months of exercise intervention4 months of exercise intervention in healthy previously sedentary participants leads to exercise-induced changes in the cardio protective miRNA expression profiles
Change from baseline in miRNA expression response to acute all-out exercise (ergometry) at 4 monthsafter 4 months of exercise intervention4 months of exercise intervention in healthy previously sedentary participants leads to a change in the acute exercise response (all-out ergometry).

Secondary

MeasureTime frameDescription
body compositionBefore and after 4 months of exercise interventionbody composition will be measured before and after intervention
exercise capacityBefore and after 4 months of exercise interventionexercise capacity will be measured by graded exercise testing on cycle ergometer.
Heart rateBefore and after 4 months of exercise interventionHeart rate will be measured by graded exercise testing on cycle ergometer.
digital application4 months of exercise interventionuser feedback and user experience will be evaluated after the intervention
body weightBefore and after 4 months of exercise interventionbody weight will be measured before and after intervention
blood lipidesBefore and after 4 months of exercise interventionblood lipides will be measured before and after intervention
arterial stiffnessBefore and after 4 months of exercise interventionarterial stiffness will be measured before and after intervention

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026