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

Sedentary Behavior Clinical Trial

— miR-4-heart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791306
• Other study ID #: UISM-13
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
Paracelsus Medical University	Ludwig Boltzmann Institute for Digital Health and Prevention

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNA expression response to acute all-out exercise (ergometry)	expression change of miRNA due to all-out ergometry at baseline	Baseline
Primary	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
Primary	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	Heart rate	Heart rate will be measured by graded exercise testing on cycle ergometer.	Before and after 4 months of exercise intervention
Secondary	blood lipides	blood lipides will be measured before and after intervention	Before and after 4 months of exercise intervention
Secondary	arterial stiffness	arterial stiffness will be measured before and after intervention	Before and after 4 months of exercise intervention
Secondary	body composition	body composition will be measured before and after intervention	Before and after 4 months of exercise intervention
Secondary	exercise capacity	exercise capacity will be measured by graded exercise testing on cycle ergometer.	Before and after 4 months of exercise intervention
Secondary	body weight	body weight will be measured before and after intervention	Before and after 4 months of exercise intervention
Secondary	digital application	user feedback and user experience will be evaluated after the intervention	4 months of exercise intervention