NCT04791306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

March 4, 2021

Last Update Submit

April 3, 2024

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (3)

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

    expression change of miRNA due to all-out ergometry at baseline

    Baseline

  • 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

  • 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 Outcomes (7)

  • Heart rate

    Before and after 4 months of exercise intervention

  • blood lipides

    Before and after 4 months of exercise intervention

  • arterial stiffness

    Before and after 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

  • +2 more secondary outcomes

Study Arms (1)

Exercise Training

EXPERIMENTAL

All participants should increase their physical activity level to at least 150 min per week, guided with once a week supervised in-house training as well as an application for planning and documentation for home-based physical activity

Other: supervised exercise trainingOther: home-based exercise training

Interventions

supervised exercise trainingOTHER

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

Exercise Training
home-based exercise trainingOTHER

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.

Exercise Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<150min physical activity per week
  • \>18 years of age
  • male and female
  • signed inform consents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Prof. Josef Niebauer, MD PhD MBA

    Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Univ.Prof.Dr.Dr. Josef Niebauer, MBA

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

July 1, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

AU(1)