NCT04187170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

November 17, 2019

Last Update Submit

February 11, 2024

Conditions

Keywords

Right ventriclecardiac physiologystrength trainingechocardiography

Outcome Measures

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

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

Study Arms (1)

Healthy sedentary subjects exposed to the training program

EXPERIMENTAL
Other: Strength physical training

Interventions

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.

Healthy sedentary subjects exposed to the training program

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Caen

Caen, Normandy, 14000, France

Location

Related Publications (2)

  • Pamart N, Drigny J, Azambourg H, Remilly M, Lahjaily K, Rocamora A, Tournoux F, Saloux E, Reboursiere E, Gauthier A, Hodzic A. Association between muscle strength gains and biventricular cardiac remodeling in response to high-intensity resistance training in healthy untrained males: a longitudinal study. BMC Sports Sci Med Rehabil. 2025 May 7;17(1):116. doi: 10.1186/s13102-025-01165-8.

  • Pamart N, Drigny J, Azambourg H, Remilly M, Macquart M, Lefevre A, Lahjaily K, Parienti JJ, Rocamora A, Guermont H, Desvergee A, Ollitrault P, Tournoux F, Saloux E, Normand H, Reboursiere E, Gauthier A, Hodzic A. 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. JMIR Form Res. 2023 Oct 24;7:e47876. doi: 10.2196/47876.

Related Links

MeSH Terms

Conditions

Ventricular RemodelingHypertrophy, Right Ventricular

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2019

First Posted

December 5, 2019

Study Start

January 13, 2022

Primary Completion

June 20, 2023

Study Completion

August 20, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations