AthletesNCT01463761
Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes
An observational study of Athletes and Training, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- What is being tested?
- ANS activity
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 8 sitesFrance
- Study dates
- Jul 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: High-level athlete, enrolled in a Ministry-recognized Pôle
Who may be able to join
- High-level athlete, enrolled in a Ministry-recognized Pôle
- Participant signed the informed consent form
Who cannot join
- Confirmed current overtraining syndrome
- Known pregnancy on inclusion
- Athlete using cardio-inhibitor or cardio-accelerator drugs
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CH Albertville Moutiers
Albertville, 73200
CHU de Besançon
Besançon, 25000
Université Paris XIII
Bobigny, 93000
CHU de Grenoble
Grenoble, 38000
CHU de Pointe à Pitre
Pointe à Pitre, 97110
CNSN Centre médical de Prémanon
Prémanon, 39400
CHU de Saint-Etienne
Saint-Etienne, 42000
CREPS Toulouse Midi Pyrénées
Toulouse, 31000
About this study
Official title: 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.
Read the 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.
- Being tested
- ANS activity
- Keywords
- High-level athlete, ANS activity, Overtraining
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS activityDevice
This ANS activity is measured by nocturnal heart rates records with Holter ECG.
| Study group | Role | What they receive |
|---|---|---|
| high-level athletes | High-level athlete, enrolled in a Ministry-recognized Pôle Receives: Device: ANS activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic nervous system (ANS) activity
This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.
Measured: One year
Fatigue and physical training
Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance
Measured: One year
Secondary outcomes (5)
kinetic of the ANS activity
ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability
Measured: Every 15 days (from the iclusion to one year)
orthostasis test
ANS activity measurements (RR variability) during active orthostasis transition on waking up in the morning
Measured: Every 15 days (from inclusion to one year)
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.
Measured: Every 15 days (from inclusion to one year)
POMS (Profile of Mood States) questionnaire
Measured: Every 3 months (from inclusion to inclusion)
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.)
Measured: Every 3 months (from inclusion to one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Minister of Youth Affairs and Sports, France
- Responsible party
- Sponsor
- Investigators
- Frederic ROCHE, MD PhD, Principal investigator, CHU de Saint-EtienneXavier BIGARD, MD PhD, Study chair, Institut de Recherche Biomédicales des Armées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463761
- Sponsor's protocol ID
- 0908073
- Other IDs
- 2009-A00674-53
- Status last verified
- Mar 2013
- First submitted
- 31 Oct 2011
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study
- ClinicalTrials.gov ID
- NCT01463761
- Acronym / sponsor ID
- 0908073
- Keywords
- High-level athlete, ANS activity, Overtraining
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Minister of Youth Affairs and Sports, France
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-level athletes | – | Device: ANS activityHigh-level athlete, enrolled in a Ministry-recognized Pôle |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- High-level athlete, enrolled in a Ministry-recognized Pôle
Key inclusion criteria (2 listed)
- High-level athlete, enrolled in a Ministry-recognized Pôle
- Participant signed the informed consent form
Key exclusion criteria (3 listed)
- Confirmed current overtraining syndrome
- Known pregnancy on inclusion
- Athlete using cardio-inhibitor or cardio-accelerator drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS activityThis ANS activity is measured by nocturnal heart rates records with Holter ECG. | Device | high-level athletes |
Primary outcome
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.
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
5 secondary outcomes
kinetic of the ANS activity
Time frame: Every 15 days (from the iclusion to one year)
orthostasis test
Time frame: Every 15 days (from inclusion to one year)
French Society of Sports Medicine questionnaire
Time frame: Every 15 days (from inclusion to one year)
POMS (Profile of Mood States) questionnaire
Time frame: Every 3 months (from inclusion to inclusion)
Sleep quality questionnaire
Time frame: Every 3 months (from inclusion to one year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic ROCHE, MD PhD principal investigator
CHU de Saint-Etienne
Xavier BIGARD, MD PhD study chair
Institut de Recherche Biomédicales des Armées
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletes and Training, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic nervous system (ANS) activity (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.