Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes

Fatigue Clinical Trial

Official title:

Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463761
• Other study ID #: 0908073
• Secondary ID: 2009-A00674-53
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: March 5, 2013
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Athletes
• Fatigue
• Training

Intervention

Device:
• ANS activity
This ANS activity is measured by nocturnal heart rates records with Holter ECG.

Locations

Country	Name	City	State
France	CH Albertville Moutiers	Albertville
France	CHU de Besançon	Besancon
France	Université Paris XIII	Bobigny
France	CHU de Grenoble	Grenoble
France	CHU de Pointe à Pitre	Pointe A Pitre
France	CNSN Centre médical de Prémanon	Premanon
France	CHU de Saint-Etienne	Saint-Etienne
France	CREPS Toulouse Midi Pyrénées	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Minister of Youth Affairs and Sports, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic nervous system (ANS) activity	This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.	One year	No
Primary	Fatigue and physical training	Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance	One year	No
Secondary	kinetic of the ANS activity	ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability	Every 15 days (from the iclusion to one year)	No
Secondary	orthostasis test	ANS activity measurements (RR variability) during active orthostasis transition on waking up in the morning	Every 15 days (from inclusion to one year)	No
Secondary	French Society of Sports Medicine questionnaire	The questionnaire was designed to detect early signs of overtraining. It includes 54 yes/no questions. Subjects who answer "yes" to more than 20 questions are considered at risk for overtraining.	Every 15 days (from inclusion to one year)	No
Secondary	POMS (Profile of Mood States) questionnaire		Every 3 months (from inclusion to inclusion)	No
Secondary	Sleep quality questionnaire	The questionnaire is self-administered. It includes two parts. The first part consists of several questions regarding sleep during the previous night. The second part aims to evaluate the physical exertion load during the previous day's training session(s). Participants will fill one questionnaire/day for a whole week. Each questionnaire period must coincide with a training period (interseason, volume, intensity, or competition.)	Every 3 months (from inclusion to one year)	No