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

Primary Purpose

Cardiac Remodeling, Ventricular, Right Ventricular Hypertrophy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strength physical training
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Remodeling, Ventricular focused on measuring Right ventricle, cardiac physiology, strength training, echocardiography

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • University Hospital of CaenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy sedentary subjects exposed to the training program

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2019
Last Updated
December 13, 2019
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04187170
Brief Title
Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography
Acronym
FORCE-VD
Official Title
Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Remodeling, Ventricular, Right Ventricular Hypertrophy
Keywords
Right ventricle, cardiac physiology, strength training, echocardiography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy sedentary subjects exposed to the training program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Strength physical training
Intervention Description
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 Outcome Measure Information:
Title
Assessment of right ventricular volumes change over 6 months of sustained high-strength physical training.
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir HODZIC, MD
Phone
33 231063106
Ext
4531
Email
hodzic-a@chu-caen.fr
Facility Information:
Facility Name
University Hospital of Caen
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir HODZIC, MD
Phone
33 231063106
Ext
4531
Email
hodzic-a@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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