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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
History of Changes
  Purpose

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.


Condition Intervention
Athletes
Training
Fatigue
 Device: ANS activity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.)


Enrollment: 131
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
high-level athletes
High-level athlete, enrolled in a Ministry-recognized Pôle
 Device: ANS activity
This ANS activity is measured by nocturnal heart rates records with Holter ECG.

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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463761

Locations
France
CH Albertville Moutiers
Albertville, France, 73200
CHU de Besançon
Besancon, France, 25000
Université Paris XIII
Bobigny, France, 93000
CHU de Grenoble
Grenoble, France, 38000
CHU de Pointe à Pitre
Pointe A Pitre, France, 97110
CNSN Centre médical de Prémanon
Premanon, France, 39400
CHU de Saint-Etienne
Saint-Etienne, France, 42000
CREPS Toulouse Midi Pyrénées
Toulouse, France, 31000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Minister of Youth Affairs and Sports, France
Investigators
Principal Investigator: Frederic ROCHE, MD PhD CHU de Saint-Etienne
Study Chair: Xavier BIGARD, MD PhD Institut de Recherche Biomédicales des Armées
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01463761     History of Changes
Other Study ID Numbers: 0908073, 2009-A00674-53
Study First Received: October 31, 2011
Last Updated: March 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
High-level athlete
ANS activity
Overtraining

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013