- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463761
Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes
March 5, 2013 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
131
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Albertville, France, 73200
- CH Albertville Moutiers
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Besancon, France, 25000
- CHU de Besançon
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Bobigny, France, 93000
- Université Paris XIII
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Grenoble, France, 38000
- CHU de Grenoble
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Pointe A Pitre, France, 97110
- CHU de Pointe à Pitre
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Premanon, France, 39400
- CNSN Centre médical de Prémanon
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Saint-Etienne, France, 42000
- CHU de Saint-Etienne
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Toulouse, France, 31000
- CREPS Toulouse Midi Pyrénées
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
High-level athlete, enrolled in a Ministry-recognized Pôle
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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high-level athletes
High-level athlete, enrolled in a Ministry-recognized Pôle
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This ANS activity is measured by nocturnal heart rates records with Holter ECG.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Autonomic nervous system (ANS) activity
Time Frame: One year
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This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.
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One year
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Fatigue and physical training
Time Frame: One year
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Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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kinetic of the ANS activity
Time Frame: Every 15 days (from the iclusion to one year)
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ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability
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Every 15 days (from the iclusion to one year)
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orthostasis test
Time Frame: Every 15 days (from inclusion to one year)
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ANS activity measurements (RR variability) during active orthostasis transition on waking up in the morning
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Every 15 days (from inclusion to one year)
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French Society of Sports Medicine questionnaire
Time Frame: Every 15 days (from inclusion to one year)
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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.
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Every 15 days (from inclusion to one year)
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POMS (Profile of Mood States) questionnaire
Time Frame: Every 3 months (from inclusion to inclusion)
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Every 3 months (from inclusion to inclusion)
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Sleep quality questionnaire
Time Frame: Every 3 months (from inclusion to one year)
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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.)
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Every 3 months (from inclusion to one year)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Xavier BIGARD, MD PhD, Institut de Recherche Biomédicales des Armées
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
October 31, 2011
First Submitted That Met QC Criteria
November 1, 2011
First Posted (ESTIMATE)
November 2, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 6, 2013
Last Update Submitted That Met QC Criteria
March 5, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0908073
- 2009-A00674-53 (OTHER: AFSSAPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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