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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • Albertville, France, 73200
        • CH Albertville Moutiers
      • Besancon, France, 25000
        • CHU De Besancon
      • Bobigny, France, 93000
        • Université Paris XIII
      • Grenoble, France, 38000
        • CHU de Grenoble
      • Pointe A Pitre, France, 97110
        • CHU de Pointe à Pitre
      • Premanon, France, 39400
        • CNSN Centre médical de Prémanon
      • Saint-Etienne, France, 42000
        • CHU de Saint-Etienne
      • Toulouse, France, 31000
        • CREPS Toulouse Midi Pyrénées

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Autonomic nervous system (ANS) activity
Time Frame: One year
This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.
One year
Fatigue and physical training
Time Frame: One year
Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance
One year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
kinetic of the ANS activity
Time Frame: Every 15 days (from the iclusion to one year)
ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability
Every 15 days (from the iclusion to one year)
orthostasis test
Time Frame: Every 15 days (from inclusion to one year)
ANS activity measurements (RR variability) during active orthostasis transition on waking up in the morning
Every 15 days (from inclusion to one year)
French Society of Sports Medicine questionnaire
Time Frame: Every 15 days (from inclusion to one year)
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)
POMS (Profile of Mood States) questionnaire
Time Frame: Every 3 months (from inclusion to inclusion)
Every 3 months (from inclusion to inclusion)
Sleep quality questionnaire
Time Frame: Every 3 months (from inclusion to one year)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Minister of Youth Affairs and Sports, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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