Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-04-18 @ 4:03 PM
Study NCT ID:
NCT01993056
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-22', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-22', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'injury incidence', 'timeFrame': 'August 2011 - June 2012', 'description': 'injury incidence (injuries per 1000h of soccer)'}]}, 'conditionsModule': {'keywords': ['injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up'], 'conditions': ['Injury']}, 'descriptionModule': {'briefSummary': 'According to available data the injury rate in male veteran soccer is high. Interventions to prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and consists of several exercises with an overall-length of about 20 min. This study shall investigate the influence of 11+ on injury incidence and Functional Movement Screen (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a relationship between FMS-Score and injury incidence. For this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. Injuries are documented via questionnaires in accordance with the FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '32 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis\n\nExclusion Criteria:\n\n* major time-loss injury, chronic inflammatory joint disease'}, 'identificationModule': {'nctId': 'NCT01993056', 'briefTitle': 'The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'orgStudyIdInfo': {'id': 'Saarland University 10/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'warm-up with 11+', 'description': 'The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries', 'interventionNames': ['Behavioral: "FIFA 11+"']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'the control group follows its regular training routine', 'interventionNames': ['Behavioral: no "FIFA 11+"']}], 'interventions': [{'name': '"FIFA 11+"', 'type': 'BEHAVIORAL', 'armGroupLabels': ['warm-up with 11+']}, {'name': 'no "FIFA 11+"', 'type': 'BEHAVIORAL', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66111', 'city': 'Saarbrücken', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Saarland University', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}], 'overallOfficials': [{'name': 'Daniel Hammes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saarland University, Institute for Sports and Preventive Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'collaborators': [{'name': 'FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Anne Krieg M.D.', 'investigatorAffiliation': 'Universität des Saarlandes'}}}}