Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-28 @ 6:00 PM
Study NCT ID:
NCT01463761
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2011-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2011-10-31', 'studyFirstSubmitQcDate': '2011-11-01', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autonomic nervous system (ANS) activity', 'timeFrame': 'One year', 'description': 'This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.'}, {'measure': 'Fatigue and physical training', 'timeFrame': 'One year', 'description': 'Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance'}], 'secondaryOutcomes': [{'measure': 'kinetic of the ANS activity', 'timeFrame': 'Every 15 days (from the iclusion to one year)', 'description': 'ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability'}, {'measure': 'orthostasis test', 'timeFrame': 'Every 15 days (from inclusion to one year)', 'description': 'ANS activity measurements (RR variability) during active orthostasis transition on waking up in the morning'}, {'measure': 'French Society of Sports Medicine questionnaire', 'timeFrame': 'Every 15 days (from inclusion to one year)', 'description': '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.'}, {'measure': 'POMS (Profile of Mood States) questionnaire', 'timeFrame': 'Every 3 months (from inclusion to inclusion)'}, {'measure': 'Sleep quality questionnaire', 'timeFrame': 'Every 3 months (from inclusion to one year)', 'description': "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.)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-level athlete', 'ANS activity', 'Overtraining'], 'conditions': ['Athletes', 'Training', 'Fatigue']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'High-level athlete, enrolled in a Ministry-recognized Pôle', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High-level athlete, enrolled in a Ministry-recognized Pôle\n* Participant signed the informed consent form\n\nExclusion Criteria:\n\n* Confirmed current overtraining syndrome\n* Known pregnancy on inclusion\n* Athlete using cardio-inhibitor or cardio-accelerator drugs'}, 'identificationModule': {'nctId': 'NCT01463761', 'briefTitle': 'Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study', 'orgStudyIdInfo': {'id': '0908073'}, 'secondaryIdInfos': [{'id': '2009-A00674-53', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'high-level athletes', 'description': 'High-level athlete, enrolled in a Ministry-recognized Pôle', 'interventionNames': ['Device: ANS activity']}], 'interventions': [{'name': 'ANS activity', 'type': 'DEVICE', 'description': 'This ANS activity is measured by nocturnal heart rates records with Holter ECG.', 'armGroupLabels': ['high-level athletes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73200', 'city': 'Albertville', 'country': 'France', 'facility': 'CH Albertville Moutiers', 'geoPoint': {'lat': 45.67452, 'lon': 6.39061}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Université Paris XIII', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '97110', 'city': 'Pointe à Pitre', 'country': 'France', 'facility': 'CHU de Pointe à Pitre', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'zip': '39400', 'city': 'Prémanon', 'country': 'France', 'facility': 'CNSN Centre médical de Prémanon', 'geoPoint': {'lat': 46.46284, 'lon': 6.01896}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'CREPS Toulouse Midi Pyrénées', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Frederic ROCHE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}, {'name': 'Xavier BIGARD, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut de Recherche Biomédicales des Armées'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minister of Youth Affairs and Sports, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}