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

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT04187170

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Remodeling, Ventricular Right Ventricular Hypertrophy	Other: Strength physical training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 31, 2019

Anticipated Primary Completion Date :

Jul 15, 2021

Anticipated Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy sedentary subjects exposed to the training program	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.

Arm

Intervention/Treatment

Experimental: Healthy sedentary subjects exposed to the training program

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.

Outcome Measures

Primary Outcome Measures

Assessment of right ventricular volumes change over 6 months of sustained high-strength physical training. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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).