Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes
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| First Received Date ICMJE | October 31, 2011 | ||||||||
| Last Updated Date | March 5, 2013 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01463761 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes | ||||||||
| Official Title ICMJE | Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study | ||||||||
| Brief 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 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | High-level athlete, enrolled in a Ministry-recognized Pôle |
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| Condition ICMJE |
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| Intervention ICMJE | Device: ANS activity
This ANS activity is measured by nocturnal heart rates records with Holter ECG. |
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| Study Group/Cohort (s) | high-level athletes
High-level athlete, enrolled in a Ministry-recognized Pôle
Intervention: Device: ANS activity |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 131 | ||||||||
| Completion Date | December 2012 | ||||||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 14 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01463761 | ||||||||
| Other Study ID Numbers ICMJE | 0908073, 2009-A00674-53 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Collaborators ICMJE | Minister of Youth Affairs and Sports, France | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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