Clinical trial NCT04791306: Impact of 4 Months of Exercise Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals
Official title: Impact of a 4 Months Training Intervention on Exercise-induced Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Institute for Digital Health and Prevention
First posted: 2021-03-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: miRNA expression response to acute all-out exercise (ergometry)
timeFrame: Baseline
measure: Change from baseline miRNA expression at 4 months
timeFrame: after 4 months of exercise intervention
measure: Change from baseline in miRNA expression response to acute all-out exercise (ergometry) at 4 months
timeFrame: after 4 months of exercise intervention
Secondary outcomes:
measure: Heart rate
timeFrame: Before and after 4 months of exercise intervention
measure: blood lipides
timeFrame: Before and after 4 months of exercise intervention
measure: arterial stiffness
timeFrame: Before and after 4 months of exercise intervention
measure: body composition
timeFrame: Before and after 4 months of exercise intervention
measure: exercise capacity
timeFrame: Before and after 4 months of exercise intervention
measure: body weight
timeFrame: Before and after 4 months of exercise intervention
measure: digital application
timeFrame: 4 months of exercise intervention
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Study officials:
affiliation: Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
name: Prof. Josef Niebauer, MD PhD MBA
role: PRINCIPAL_INVESTIGATOR
References: