FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study (FACEFI)

To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects:

• Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training;
• Young recruits in military school of officers in ground forces of the French army during an intensive.

Study Overview

• Status: Unknown
• Conditions: Muscle; Fatigue, Heart
• Intervention / Treatment: Procedure: Tests

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François FC Carré; Phone Number: 33-2-9928-3750; Email: francois.carre@chu-rennes.fr

Study Locations

• France
  • Rennes, France
    • Recruiting
    • CHU Rennes
    • Contact: François FC Carré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy men between 18 and 35 years old;
• Giving their writing informed consent;
• And affiliated to the French social security.

Exclusion Criteria:

• To be a smoker.
• To present any known pathology that forbids the realisation of any test, or that can alter the measurements: cardiovascular risk factors treated or not (diabetes, dyslipidaemia, arterial hypertension, obesity), cardiac arrhythmia, coronary disease, heart failure, cardiac pacemaker or defibrillator, valvular disease after surgery or not, kidneys failure with dialyse or not, kidney pulmonary cardiac or liver transplantation, chronic bronchopneumopathy, asthma, etc.
• To take any medication that could alter autonomic nervous system or cardiovascular adaptation to maximal exercise (anti-arrhythmia, anti-hypertensive, anti-inflammatory,…).
• Drinking exciting drinks (coffee or tee for example) in the 12h before the tests.
• To be under legal protection (trusteeship, guardianship) or to be deprived of liberty.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canoeists; 13 canoeists from a training center of the French canoeing team	Procedure: Tests; Individual parameters of echocardiography and heart rate variability
Experimental: Military; 10 young recruits in military school of officers in ground forces of the French army	Procedure: Tests; Individual parameters of echocardiography and heart rate variability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of classical echocardiographic parameters to attest systolic and diastolic functions	Speckle tracking will also be used to get strain parameters of the left ventricle. Measure will by recording daily before, during, and after a period of intensive training, in order to attest possible cardiovascular effects of such periods. Echocardiographic data will be recorded at rest and during a submaximal exercise.	day 8 (canoeists) / day 5 (military)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of classical heart rate variability parameters	Measure will by recording daily before, during, and after a period of intensive training, in order to attest possible cardiovascular effects of such periods. Measure will be recorded during 5 min resting and 5 min standing.	day 8 (canoeists) / day 5 (military)

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: François FC Carré, CHU Rennes

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 23, 2015
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Endurance training; Cardiac functions; Senior athletes
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2013-A01524-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No