ClinicalTrials.gg
CompletedNCT04187170FORCE-VDUpdated Feb 13, 2024

Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography

An interventional study of Strength physical training in Cardiac Remodeling, Ventricular and Right Ventricular Hypertrophy, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Cardiac Remodeling, Ventricular
  • Right Ventricular Hypertrophy

Keywords

  • Right ventricle
  • cardiac physiology
  • strength training
  • echocardiography
03

In context

Ventricular Remodeling

105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.

This study's enrollment of 27 is below the median of 81 across 72 interventional studies indexed under Ventricular Remodeling.

Browse Ventricular Remodeling studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 40 years
  • Male gender
  • Agree to participate in the study (signature of consent).
  • Affiliated to an insurance scheme or beneficiary

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
  • > 30 kg/m²
  • Inclusion in another biomedical research protocol (during the present study or within 6 months before inclusion).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Healthy sedentary subjects exposed to the training program

    Other: Strength physical training

Interventions

  • OtherStrength physical training

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Before the training starts and up to 6 months of follow-up

07

Study locations

1 site
  • University Hospital of Caen
    Caen, Normandie 14000, France
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Jun 2023, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2019
First posted
Dec 5, 2019
StartActual
Jan 13, 2022
Primary completionActual
Jun 20, 2023
CompletionActual
Aug 20, 2023
Last update
Feb 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04187170
Responsible party
Amir HODZIC (Principal investigator, University Hospital, Caen) — Principal investigator
First posted
Dec 5, 2019
Start date
Jan 13, 2022
Primary completion
Jun 20, 2023
Completion
Aug 20, 2023
Last update
Feb 13, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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