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Completed

NCT Number: NCT04187170

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Caen

Caen, Normandy, 14000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • Body mass index > 30 kg/m²
  • Inclusion in another biomedical research protocol (during the present study or within 6 months before inclusion).

Treatment and study plan

Strength physical training

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: FORCE-VD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2019
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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