Sedentary BehaviormiR-4-heartNCT04791306
Impact of 4 Months of Exercise Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals
A study testing supervised exercise training and home-based exercise training in people with Sedentary Behavior, run by Paracelsus Medical University at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- supervised exercise training and home-based exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- <150min physical activity per week
- >18 years of age
- male and female
- signed inform consents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Salzburg, 5020
About this study
Official title: Impact of a 4 Months Training Intervention on Exercise-induced 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.
Read the 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.
- Conditions
- Sedentary Behavior
- Being tested
- supervised exercise training, home-based exercise training
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised exercise trainingOther
Participates perform once a week for 4 months an in-house supervised endurance and strength 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: supervised exercise training; Other: home-based exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression response to acute all-out exercise (ergometry)
expression change of miRNA due to all-out ergometry at baseline
Measured: 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
Measured: 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).
Measured: after 4 months of exercise intervention
Secondary outcomes (7)
Heart rate
Heart rate will be measured by graded exercise testing on cycle ergometer.
Measured: Before and after 4 months of exercise intervention
blood lipides
blood lipides will be measured before and after intervention
Measured: Before and after 4 months of exercise intervention
arterial stiffness
arterial stiffness will be measured before and after intervention
Measured: Before and after 4 months of exercise intervention
body composition
body composition will be measured before and after intervention
Measured: Before and after 4 months of exercise intervention
exercise capacity
exercise capacity will be measured by graded exercise testing on cycle ergometer.
Measured: Before and after 4 months of exercise intervention
body weight
body weight will be measured before and after intervention
Measured: Before and after 4 months of exercise intervention
digital application
user feedback and user experience will be evaluated after the intervention
Measured: 4 months of exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jul 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
- Investigators
- Prof. Josef Niebauer, MD PhD MBA, Principal investigator, Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791306
- Sponsor's protocol ID
- UISM-13
- Acronym
- miR-4-heart
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a 4 Months Training Intervention on Exercise-induced Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals
- ClinicalTrials.gov ID
- NCT04791306
- Acronym / sponsor ID
- miR-4-heart / UISM-13
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Other: supervised exercise training, Other: home-based exercise trainingAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- <150min physical activity per week
- >18 years of age
- male and female
- signed inform consents
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised exercise trainingParticipates perform once a week for 4 months an in-house supervised endurance and strength training. | Other | Exercise Training |
| home-based exercise trainingParticipants 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. | Other | Exercise Training |
Primary outcome
miRNA expression response to acute all-out exercise (ergometry)
Time frame: Baseline
expression change of miRNA due to all-out ergometry at baseline
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
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).
7 secondary outcomes
Heart rate
Time frame: Before and after 4 months of exercise intervention
blood lipides
Time frame: Before and after 4 months of exercise intervention
arterial stiffness
Time frame: Before and after 4 months of exercise intervention
body composition
Time frame: Before and after 4 months of exercise intervention
exercise capacity
Time frame: Before and after 4 months of exercise intervention
body weight
Time frame: Before and after 4 months of exercise intervention
digital application
Time frame: 4 months of exercise intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Josef Niebauer, MD PhD MBA principal investigator
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised exercise training and home-based exercise training in people with Sedentary Behavior, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression response to acute all-out exercise (ergometry) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.