Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT00894595
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2009-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Knee Injuries in Adolescent Female Football Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4564}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-03', 'studyFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2009-05-06', 'lastUpdatePostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of ACL injury', 'timeFrame': 'One competitive football season'}], 'secondaryOutcomes': [{'measure': 'The incidence of any acute knee injury except contusion', 'timeFrame': 'One competitive football season'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incidence of ACL injury', 'Risk factors for ACL injury', 'Prevention of ACL injury or any acute knee injury'], 'conditions': ['Knee Injury']}, 'referencesModule': {'references': [{'pmid': '22556050', 'type': 'DERIVED', 'citation': 'Walden M, Atroshi I, Magnusson H, Wagner P, Hagglund M. Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ. 2012 May 3;344:e3042. doi: 10.1136/bmj.e3042.'}, {'pmid': '19545453', 'type': 'DERIVED', 'citation': 'Hagglund M, Walden M, Atroshi I. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595]. BMC Musculoskelet Disord. 2009 Jun 23;10:75. doi: 10.1186/1471-2474-10-75.'}]}, 'descriptionModule': {'briefSummary': "Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.\n\nThe investigators' hypotheses are:\n\n1. a preventive training program reduces the incidence of ACL injury, and\n2. a high match frequency and match play at senior level increase the risk of ACL injury."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teams with female football players aged 13-17 years\n\nExclusion Criteria:\n\n* Teams that did not reply to the invitation or declined participation\n* Teams having less than two scheduled training sessions per week\n* Teams already using the preventive program'}, 'identificationModule': {'nctId': 'NCT00894595', 'briefTitle': 'Preventing Knee Injuries in Adolescent Female Football Players', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'M197-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The clubs in the intervention group are instructed to perform a warm-up program at two training sessions per week throughout the entire 2009 competitive season.', 'interventionNames': ['Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The clubs in the control group are instructed to train and play as usual throughout the 2009 season', 'interventionNames': ['Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005']}], 'interventions': [{'name': 'Knäkontroll, SISU Idrottsböcker©, Sweden, 2005', 'type': 'BEHAVIORAL', 'description': 'The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 83', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Department of Medical and Health Sciences, Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Markus Waldén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Football Association', 'class': 'UNKNOWN'}, {'name': 'Folksam', 'class': 'OTHER'}, {'name': 'Swedish National Centre for Research in Sports', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Markus Waldén, MD, PhD', 'oldOrganization': 'Linköping University'}}}}