Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-02-19 @ 1:14 PM
Study NCT ID:
NCT04666935
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention group will be instructed to include the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program as a warm up before training session (3 times per week) during one season (6 months).The control group will practice their usual warm up.\n\nUsual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-12', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of initial injuries.', 'timeFrame': 'At the end of the intervention season (6 months).', 'description': 'Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.'}, {'measure': 'The incidence of recurrent injuries', 'timeFrame': 'At the end of the intervention season (6 months)', 'description': 'Recurrent injury is defined as a repeat episode of a fully recovered injury. Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.'}], 'secondaryOutcomes': [{'measure': 'injury severity', 'timeFrame': 'At time of any injury occurring throughout intervention soccer season (6 months)', 'description': 'Defined as time loss in days (days unable to train): minor (1 to 7 days lost), moderate (8 to 21 days lost), or severe (\\>21 days lost). Injury severity data will be collected from Sports Injury Tracker injury reporting form.'}, {'measure': 'Compliance with the intervention', 'timeFrame': 'At the end of the intervention season (6 months)', 'description': 'the rate of compliance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oslo Sports Trauma Research Center', 'Injury Prevention Program'], 'conditions': ['Sport Injury']}, 'referencesModule': {'references': [{'pmid': '31394009', 'type': 'BACKGROUND', 'citation': 'Al Attar WSA, Alshehri MA. A meta-analysis of meta-analyses of the effectiveness of FIFA injury prevention programs in soccer. Scand J Med Sci Sports. 2019 Dec;29(12):1846-1855. doi: 10.1111/sms.13535. Epub 2019 Sep 5.'}, {'pmid': '28939307', 'type': 'BACKGROUND', 'citation': 'Al Attar WSA, Soomro N, Pappas E, Sinclair PJ, Sanders RH. Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial. J Physiother. 2017 Oct;63(4):235-242. doi: 10.1016/j.jphys.2017.08.004. Epub 2017 Sep 20.'}, {'pmid': '26403470', 'type': 'BACKGROUND', 'citation': 'Al Attar WS, Soomro N, Pappas E, Sinclair PJ, Sanders RH. How Effective are F-MARC Injury Prevention Programs for Soccer Players? A Systematic Review and Meta-Analysis. Sports Med. 2016 Feb;46(2):205-17. doi: 10.1007/s40279-015-0404-x.'}]}, 'descriptionModule': {'briefSummary': 'The Oslo Sports Trauma Research Center (OSTRC) was established in May 2000 at the Norwegian School of Sport Sciences.The OSTRC aims to prevent injuries and other health problems related to sports. The majority of the research conducted at OSTRC involves elite sports.\n\nThe purpose of this study is to investigate the effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program in reducing injuries among athletes.\n\nHypothesis: that Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program has a beneficial effect in terms of injury prevention.\n\nThe purpose of this study is to investigate the effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program in reducing injuries among athletes.', 'detailedDescription': 'Study type Interventional Description of intervention(s) / exposure: The intervention group will be instructed to include the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program as a warm up before training session (3 times per week) during one season (6 months).\n\nGroup sessions will be administered by an exercise physiologist and/ or athletic trainer and/ or soccer coaches and/ or strength and conditioning specialists and/ or physiotherapist.\n\nSession attendance checklists will be used to assess or monitor adherence to the intervention.\n\nComparator / control treatment The control group will practice their usual warm up.\n\nUsual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Amateur Athletes\n* Training at least three times per week\n\nExclusion Criteria:\n\n* History of lower extremity injury requiring medical attention in the past 6 months\n* Systemic diseases\n* Cardiovascular disease\n* Neurological disorders\n* Bone fractures\n* Surgery in the previous year.'}, 'identificationModule': {'nctId': 'NCT04666935', 'briefTitle': 'The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes.', 'organization': {'class': 'OTHER', 'fullName': 'Umm Al-Qura University'}, 'officialTitle': 'The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes. a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'HAPO-02-K-012-2020-10-465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group will be instructed to include the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program as a warm up before training session (3 times per week) during one season (6 months).', 'interventionNames': ['Other: The Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group will practice their usual warm up. Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.', 'interventionNames': ['Other: Usual warm up']}], 'interventions': [{'name': 'The Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program', 'type': 'OTHER', 'description': 'Sport Injury Prevention Program.', 'armGroupLabels': ['Intervention group']}, {'name': 'Usual warm up', 'type': 'OTHER', 'description': 'Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21955', 'city': 'Mecca', 'country': 'Saudi Arabia', 'facility': 'Umm Al Qura University', 'geoPoint': {'lat': 21.42664, 'lon': 39.82563}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Start: Immediately following publication. End: 5 years', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after de-identification will be shared.', 'accessCriteria': 'Access subject to approvals by Principal Investigator. The Principal Investigator can be contacted by email wsattar@uqu.edu.sa'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umm Al-Qura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wesam Saleh A. Al Attar, PT, MSc, PhD', 'investigatorAffiliation': 'Umm Al-Qura University'}}}}