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

Cardiac Remodeling, Ventricular Clinical Trial

— FORCE-VD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187170
• Other study ID #: 19-092
• Status: Completed
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: August 20, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Remodeling, Ventricular
• Hypertrophy
• Right Ventricular Hypertrophy
• Ventricular Remodeling

Intervention

Other:
• Strength 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.

Locations

Country	Name	City	State
France	University Hospital of Caen	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Before the training starts and up to 6 months of follow-up

External Links

•   Abstract Journées Européennes de la Société Française de Cardiologie 2024
•   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