Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-06 @ 8:26 PM
Study NCT ID:
NCT03307434
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2017-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C033561', 'term': '2-amino-5-iodo-6-phenyl-4-pyrimidinone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 880}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2017-10-10', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'injury complaint and have a consequence on the practice', 'timeFrame': 'at 40 weeks', 'description': 'Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).'}], 'secondaryOutcomes': [{'measure': 'injury complaint number and hours number of athletic practice', 'timeFrame': 'at 40 weeks', 'description': 'Correlation between injury complaint number and hours number of athletic practice'}, {'measure': 'injury complaint number and weeks number of athletic practice', 'timeFrame': 'at 40 weeks', 'description': 'Correlation between injury complaint number and weeks number of athletic practice'}, {'measure': 'week without injury complaints', 'timeFrame': 'at 40 weeks', 'description': 'Frequency of week without injury complaints'}, {'measure': 'injury complaint number at the training', 'timeFrame': 'at 40 weeks', 'description': 'Frequency of injury complaint number at the training'}, {'measure': 'injury complaint number and at the competition', 'timeFrame': 'at 40 weeks', 'description': 'Frequency of injury complaint number at the competition'}, {'measure': 'type of injury complaint between 4 consequences', 'timeFrame': 'at 40 weeks', 'description': 'the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice'}, {'measure': 'injury complaint number by groups', 'timeFrame': 'at 40 weeks', 'description': 'Correlation of injury complaint number by groups'}, {'measure': 'injury complaint type', 'timeFrame': 'at 40 weeks', 'description': 'Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Program', 'Prevention', 'Injury', 'Athletics'], 'conditions': ['Athletics', 'Wounds and Injuries', 'Prevention Program']}, 'referencesModule': {'references': [{'pmid': '39232249', 'type': 'DERIVED', 'citation': 'Iatropoulos S, Dandrieux PE, Navarro L, Blanco D, Edouard P. The Dose-Response Relationship of an Exercise-Based Injury Prevention Program: A Secondary Analysis of a Randomized Controlled Trial on Athletics (Track-and-Field) Athletes Over a 39-Week Follow-Up. Scand J Med Sci Sports. 2024 Sep;34(9):e14720. doi: 10.1111/sms.14720.'}, {'pmid': '38089679', 'type': 'DERIVED', 'citation': 'Edouard P, Tondut J, Hollander K, Dandrieux PE, Navarro L, Bruneau A, Junge A, Blanco D. Risk factors for injury complaints leading to restricted participation in Athletics (Track and Field): a secondary analysis of data from 320 athletes over one season. BMJ Open Sport Exerc Med. 2023 Dec 7;9(4):e001718. doi: 10.1136/bmjsem-2023-001718. eCollection 2023.'}, {'pmid': '34769849', 'type': 'DERIVED', 'citation': 'Edouard P, Steffen K, Peuriere M, Gardet P, Navarro L, Blanco D. Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Oct 28;18(21):11334. doi: 10.3390/ijerph182111334.'}]}, 'descriptionModule': {'briefSummary': 'The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. In team sports, injury prevention programs have been implemented and scientifically validated. However, no injury prevention programs have been implemented and scientifically validated for Athletics. In this context, a primary objective will be to analyze the effectiveness of an Athletics Injury Prevention Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one injury complaint related to athletic practice at long term (40 weeks). A statistician will carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP), multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs and followed during an athletic season.', 'detailedDescription': 'The person in charge of the platform will collect on a weekly basis via a IT-questionnaire sent out automatically every Monday the following parameters: injury complaints (presence or absence, and characteristics if presence) and exposure (number of hours of athletic practice (training and competition) and intensity), and the number of AIPP realization per week. The main criterion will be the frequency (percentage) of athletes presenting at least one injury complaint that have a consequence on the practice (reduction or cessation of practice).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* To dismissed in athletics clubs affiliated to French Federation of Athletics\n* To practice one of the disciplines of athletics\n* Men or women aged between 15 and 40 years\n\nExclusion Criteria:\n\n\\- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent"}, 'identificationModule': {'nctId': 'NCT03307434', 'acronym': 'PREVATHLE', 'briefTitle': 'To Evaluate the Effectiveness of an Injury Prevention Program in Athletics', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics', 'orgStudyIdInfo': {'id': '1708116'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2017-A01980-53'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'experimental group is composed of athletes will be followed the Athletics Injury Prevention Program', 'interventionNames': ['Other: Athletics Injury Prevention Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'control group is composed of athletes will be continued their regular training', 'interventionNames': ['Other: regular training']}], 'interventions': [{'name': 'Athletics Injury Prevention Program', 'type': 'OTHER', 'otherNames': ['AIPP'], 'description': 'The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.', 'armGroupLabels': ['experimental group']}, {'name': 'regular training', 'type': 'OTHER', 'otherNames': ['standard practice'], 'description': 'The regular training will be performed by control group according to the standard practice.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Pascal EDOUARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}