FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study

Muscle; Fatigue, Heart Clinical Trial

— FACEFI  

Official title:

FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126891
• Other study ID #: 2013-A01524-41
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: January 23, 2015
• Start date: January 2014

Study information

• Verified date: April 2014
• Source: Rennes University Hospital
• Contact: François FC Carré
• Phone: 33-2-9928-3750
• Email: francois.carre[@]chu-rennes.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fatigue
• Muscle; Fatigue, Heart

Intervention

Procedure:
• Tests
Individual parameters of echocardiography and heart rate variability

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No