NCT02126891

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

January 26, 2015

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

April 28, 2014

Last Update Submit

January 23, 2015

Conditions

Keywords

Cardiac functionsEndurance trainingSenior athletes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measure of classical heart rate variability parameters

    day 8 (canoeists) / day 5 (military)

Study Arms (2)

Canoeists

EXPERIMENTAL

13 canoeists from a training center of the French canoeing team

Procedure: Tests

Military

EXPERIMENTAL

10 young recruits in military school of officers in ground forces of the French army

Procedure: Tests

Interventions

TestsPROCEDURE

Individual parameters of echocardiography and heart rate variability

CanoeistsMilitary

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • François FC Carré

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

April 30, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Last Updated

January 26, 2015

Record last verified: 2014-04

Locations