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

This study has been completed.
Sponsor:
Collaborator:
Minister of Youth Affairs and Sports, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01463761
First received: October 31, 2011
Last updated: March 5, 2013
Last verified: March 2013

October 31, 2011
March 5, 2013
July 2010
December 2012   (final data collection date for primary outcome measure)
  • Autonomic nervous system (ANS) activity [ Time Frame: One year ] [ Designated as safety issue: No ]
    This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.
  • Fatigue and physical training [ Time Frame: One year ] [ Designated as safety issue: No ]
    Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance
Same as current
Complete list of historical versions of study NCT01463761 on ClinicalTrials.gov Archive Site
  • kinetic of the ANS activity [ Time Frame: Every 15 days (from the iclusion to one year) ] [ Designated as safety issue: No ]
    ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability
  • orthostasis test [ Time Frame: Every 15 days (from inclusion to one year) ] [ Designated as safety issue: No ]
    ANS activity measurements (RR variability) during active orthostasis transition on waking up in the morning
  • French Society of Sports Medicine questionnaire [ Time Frame: Every 15 days (from inclusion to one year) ] [ Designated as safety issue: No ]
    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.
  • POMS (Profile of Mood States) questionnaire [ Time Frame: Every 3 months (from inclusion to inclusion) ] [ Designated as safety issue: No ]
  • Sleep quality questionnaire [ Time Frame: Every 3 months (from inclusion to one year) ] [ Designated as safety issue: No ]
    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.)
Same as current
Not Provided
Not Provided
 
Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes
Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

High-level athlete, enrolled in a Ministry-recognized Pôle

  • Athletes
  • Training
  • Fatigue
Device: ANS activity
This ANS activity is measured by nocturnal heart rates records with Holter ECG.
high-level athletes
High-level athlete, enrolled in a Ministry-recognized Pôle
Intervention: Device: ANS activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01463761
0908073, 2009-A00674-53
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Minister of Youth Affairs and Sports, France
Principal Investigator: Frederic ROCHE, MD PhD CHU de Saint-Etienne
Study Chair: Xavier BIGARD, MD PhD Institut de Recherche Biomédicales des Armées
Centre Hospitalier Universitaire de Saint Etienne
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP