Clinical trial NCT01463761: Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes
Official title: Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletes
Training
Fatigue
Keywords: High-level athlete
ANS activity
Overtraining
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Minister of Youth Affairs and Sports, France
First posted: 2011-11-02
Enrollment: 131
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-level athlete, enrolled in a Ministry-recognized Pôle

Brief summary: Sports training aims to enhance an athlete's performance (overcompensation). To do that, the athlete must go through periods of fatigue and lower performance (overreaching). When the training plan is balanced, this fatigue is short and reversible.If the training load is too heavy or if recuperation periods are too short, it can lead to persistence fatigue that may only be reversible in the long term. This state of fatigue is part of the broader clinical picture of overtraining, which includes stark changes in performance as well as mood and sleep disorders. Many prediction and characterization methods based on biological markers have been evaluated, but they have not been put into practice in sports training due to obstacles such as reliability, interindividual variability and high costs. This study aims to evaluate a new approach based on the variability of an individual's heart rate (RR variability), which is a way of measuring autonomic nervous system (ASN) activity. It is non-invasive, low-cost, and has already proven useful in athlete health monitoring.

Detailed description: The investigators propose to describe the variation of these ANS regulation factors over a full year, in a population of high-level athletes, in order to measure changes in regulation which may be predictive of potential fatigue and intolerance to physical training, if such a syndrome came to be observed among the study group.

Eligibility criteria: Inclusion Criteria:

* High-level athlete, enrolled in a Ministry-recognized Pôle
* Participant signed the informed consent form

Exclusion Criteria:

* Confirmed current overtraining syndrome
* Known pregnancy on inclusion
* Athlete using cardio-inhibitor or cardio-accelerator drugs

Primary outcomes:
measure: Autonomic nervous system (ANS) activity
timeFrame: One year
measure: Fatigue and physical training
timeFrame: One year
Secondary outcomes:
measure: kinetic of the ANS activity
timeFrame: Every 15 days (from the iclusion to one year)
measure: orthostasis test
timeFrame: Every 15 days (from inclusion to one year)
measure: French Society of Sports Medicine questionnaire
timeFrame: Every 15 days (from inclusion to one year)
measure: POMS (Profile of Mood States) questionnaire
timeFrame: Every 3 months (from inclusion to inclusion)
measure: Sleep quality questionnaire
timeFrame: Every 3 months (from inclusion to one year)
Other outcomes:
Locations:
city: Albertville
country: France
facility: CH Albertville Moutiers
city: Besancon
country: France
facility: CHU de Besançon
city: Bobigny
country: France
facility: Université Paris XIII
city: Grenoble
country: France
facility: CHU de Grenoble
city: Pointe A Pitre
country: France
facility: CHU de Pointe à Pitre
city: Premanon
country: France
facility: CNSN Centre médical de Prémanon
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CREPS Toulouse Midi Pyrénées
Study officials:
affiliation: CHU de Saint-Etienne
name: Frederic ROCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche Biomédicales des Armées
name: Xavier BIGARD, MD PhD
role: STUDY_CHAIR
References: