Cardiac Remodeling, VentricularFORCE-VDNCT04187170
Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography
A study testing Strength physical training in people with Cardiac Remodeling, Ventricular and Right Ventricular Hypertrophy, run by University Hospital, Caen at 1 site in France.
Trial summary
Right ventricular (RV) physiological remodeling in response to prolonged strength exercise remains poorly studied. This prospective, non-randomized, single-center study, proposes to follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance training program over a 6-month period. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Remodeling, Ventricular, Right Ventricular Hypertrophy
- What is being tested?
- Strength physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2022to 20 Aug 2023
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years
- Male gender
- Agree to participate in the study (signature of consent).
- Affiliated to an insurance scheme or beneficiary
Who cannot join
- Female gender
- Inability to express consent
- Moderate physical activity over than 150 minutes or intensive physical activity over than 75 minutes per week on a regular basis for more than 6 consecutive months, according to the World Health Organisation criteria.
- Participation in competitive sports of ≥ II and / or B according to Mitchell's classification in the last 3 years.
- Ischemic and non-ischemic heart diseases
- Family history of unexplained sudden death
Show all 13Show fewer
- Personal or family history of elastic tissue disease (Marfan syndrome and related)
- Chronic diseases incompatible with physical exercise at high intensity
- Personal history of chemotherapy and / or radiotherapy
- ≥ 1 cardiovascular risk factors
- use of doping substances
- Body mass index > 30 kg/m²
- Inclusion in another biomedical research protocol (during the present study or within 6 months before inclusion).
Trial locations and contacts
1 site in 1 country.
About this study
Right ventricular (RV) physiological remodeling in response to prolonged strength exercise remains poorly studied. This prospective, non-randomized, single-center study, proposes to follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance training program over a 6-month period. The volunteers, aged between 18 and 40 years old and male, will be recruited and evaluated at the University Hospital center of Caen Normandy. Cardiac remodeling in response to physical exercise will be analyzed by trans-thoracic echocardiography repeated during the follow-up. The physical impact of the training program will be assessed by a treadmill exercise test predicting maximal oxygen consumption (VO2max) before and after completing the training, and an isokinetic muscular test repeated every 3 months. Participants rest/activity cycles will be monitor before and after 3 months of training. The aim of the study is to demonstrate the existence of a physiologic RV remodeling in response to pure high-load resistance chronic exercise. The results will help to improve the understanding of the physiological RV response expected in strength athletes.
- Being tested
- Strength physical training
- Keywords
- Right ventricle, cardiac physiology, strength training, echocardiography
- Medical subject headings
- Ventricular Remodeling, Hypertrophy, Right Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength physical trainingOther
progressive high-load strength training over 6 months, consisting in repeated physical exercises to increase the muscular mass and force by altering concentric and eccentric muscle contractions against high resistance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy sedentary subjects exposed to the training program | Experimental | Not described Receives: Other: Strength physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of right ventricular volumes change over 6 months of sustained high-strength physical training.
Analysis of variation in echocardiographic measurements of RV volumes before and after training
Measured: Before the training starts and up to 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start13 Jan 2022
- Primary completion20 Jun 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Remodeling, VentricularStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir HODZIC, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187170
- Sponsor's protocol ID
- 19-092
- Acronym
- FORCE-VD
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pamart N, Drigny J, Azambourg H, Remilly M, Lahjaily K, Rocamora A, Tournoux F, Saloux E, Reboursiere E, Gauthier A, Hodzic A. Association between muscle strength gains and biventricular cardiac remodeling in response to high-intensity resistance training in healthy untrained males: a longitudinal study. BMC Sports Sci Med Rehabil. 2025 May 7;17(1):116. doi: 10.1186/s13102-025-01165-8.
PubMed 40336139Pamart N, Drigny J, Azambourg H, Remilly M, Macquart M, Lefevre A, Lahjaily K, Parienti JJ, Rocamora A, Guermont H, Desvergee A, Ollitrault P, Tournoux F, Saloux E, Normand H, Reboursiere E, Gauthier A, Hodzic A. Effects of a 20-Week High-Intensity Strength Training Program on Muscle Strength Gain and Cardiac Adaptation in Untrained Men: Preliminary Results of a Prospective Longitudinal Study. JMIR Form Res. 2023 Oct 24;7:e47876. doi: 10.2196/47876.
PubMed 37874630
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography
- ClinicalTrials.gov ID
- NCT04187170
- Acronym / sponsor ID
- FORCE-VD / 19-092
- Keywords
- Right ventricle, cardiac physiology, strength training, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 5 Dec 2019 (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.
Right ventricular (RV) physiological remodeling in response to prolonged strength exercise remains poorly studied. This prospective, non-randomized, single-center study, proposes to follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance training program over a 6-month period. The volunteers, aged between 18 and 40 years old and male, will be recruited and evaluated at the University Hospital center of Caen Normandy. Cardiac remodeling in response to physical exercise will be analyzed by trans-thoracic echocardiography repeated during the follow-up. The physical impact of the training program will be assessed by a treadmill exercise test predicting maximal oxygen consumption (VO2max) before and after completing the training, and an isokinetic muscular test repeated every 3 months. Participants rest/activity cycles will be monitor before and after 3 months of training. The aim of the study is to demonstrate the existence of a physiologic RV remodeling in response to pure high-load resistance chronic exercise. The results will help to improve the understanding of the physiological RV response expected in strength athletes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy sedentary subjects exposed to the training program | Experimental | Other: Strength physical training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 40 years
- Male gender
- Agree to participate in the study (signature of consent).
- Affiliated to an insurance scheme or beneficiary
Key exclusion criteria (13 listed)
- Female gender
- Inability to express consent
- Moderate physical activity over than 150 minutes or intensive physical activity over than 75 minutes per week on a regular basis for more than 6 consecutive months, according to the World Health Organisation criteria.
- Participation in competitive sports of ≥ II and / or B according to Mitchell's classification in the last 3 years.
- Ischemic and non-ischemic heart diseases
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 |
|---|---|---|
| Strength physical trainingprogressive high-load strength training over 6 months, consisting in repeated physical exercises to increase the muscular mass and force by altering concentric and eccentric muscle contractions against high resistance. | Other | Healthy sedentary subjects exposed to the training program |
Primary outcome
Assessment of right ventricular volumes change over 6 months of sustained high-strength physical training.
Time frame: Before the training starts and up to 6 months of follow-up
Analysis of variation in echocardiographic measurements of RV volumes before and after training
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 13 Feb 2024.
- Derived from this study: PubMed 40336139Pamart N, Drigny J, Azambourg H, Remilly M, Lahjaily K, Rocamora A, Tournoux F, Saloux E, Reboursiere E, Gauthier A, Hodzic A. Association between muscle strength gains and biventricular cardiac remodeling in response to high-intensity resistance training in healthy untrained males: a longitudinal study. BMC Sports Sci Med Rehabil. 2025 May 7;17(1):116. doi: 10.1186/s13102-025-01165-8.
- Derived from this study: PubMed 37874630Pamart N, Drigny J, Azambourg H, Remilly M, Macquart M, Lefevre A, Lahjaily K, Parienti JJ, Rocamora A, Guermont H, Desvergee A, Ollitrault P, Tournoux F, Saloux E, Normand H, Reboursiere E, Gauthier A, Hodzic A. Effects of a 20-Week High-Intensity Strength Training Program on Muscle Strength Gain and Cardiac Adaptation in Untrained Men: Preliminary Results of a Prospective Longitudinal Study. JMIR Form Res. 2023 Oct 24;7:e47876. doi: 10.2196/47876.
- Abstract Journées Européennes de la Société Française de Cardiologie 2024Link provided by the sponsor.
- Effects of a 20-Week High-Intensity Strength Training Program on Muscle Strength Gain and Cardiac Adaptation in Untrained Men: Preliminary Results of a Prospective Longitudinal StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength physical training in people with Cardiac Remodeling, Ventricular and Right Ventricular Hypertrophy, run by University Hospital, Caen at 1 site in France.
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 13 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 13 Feb 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 France. 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?
Assessment of right ventricular volumes change over 6 months of sustained high-strength physical training. (time frame: Before the training starts and up to 6 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187170, which also lists 2 linked publications.
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 13 Feb 2024.