Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT05994469
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2023-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Groin Injuries in Rink Hockey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Natural experiment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2023-08-05', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bi-Weekly prevalence of groin problems', 'timeFrame': 'Every 14 days throughout the entire study (which lasts 7 months)', 'description': 'number of groin pain complaints in a 14-day frame, groin pain is described as pain in the groin region which emerges from performing exercise and may be indicative of an injury to the adductor muscles, abdominals, hip flexors, or pubic joint'}], 'secondaryOutcomes': [{'measure': 'Adherence to the intervention', 'timeFrame': 'Every 7 days throughout the entire study (which lasts 7 months)', 'description': 'Since the intervention is implemented on a weekly basis, the number of sessions performed by the participating teams will be collected to calculate the total compliance with the intervention. From a total of 56 possible sessions a team may complete 47 which equals 83% compliance'}, {'measure': 'hockey exposure', 'timeFrame': 'Every 7 days throughout the entire study (which lasts 7 months)', 'description': 'number of training sessions and games per week this metric is collected to calculate exposure hours, so that groin problems can be compared as nº of injuries / 1000 hours of exposure, as the International Olympic Committee recommends'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rink hockey', 'groin pain', 'injury prevention'], 'conditions': ['Groin Injury', 'Groin Strain', 'Adductor Strain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/29891614/', 'label': 'Previous research similar to this project'}, {'url': 'https://doi.org/10.1007/s00167-021-06644-2', 'label': 'Previous research similar to this project'}]}, 'descriptionModule': {'briefSummary': 'Rink hockey teams from senior category (adults) will be recruited to implement a groin injury prevention program consisting on the Copenhagen Adduction Exercise (CAE) throughout the regular season, 0 times, once or twice per week (september 2023-march 2024)\n\nWeekly team exposure to training sessions and games will be collected as well as cases of groin problems in the entire population\n\nWhen the season ends, the number of groin problems will be compared between teams that used the prevention program once a week against twice a week or no sessions a week.', 'detailedDescription': 'Rink hockey teams will be offered a prevention program consisting on the CAE to be performed during the season.\n\nTeams will decide to implement the protocol once, twice or 0 times per week, depending on their schedule. No formal control group will be set, comparison of injuries will be performed between teams that used +80% of the total possible sessions and -80% (28 weeks equals a potential 42 CAE sessions throughout the season).\n\nOn a weekly basis, coaches will be contacted to report number of training sessions, games, and training sessions where they implemented CAE.\n\nBi-weekly, players will report any episode of groin problems (both leading to time-loss and those only affecting performance while not limiting participation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* #1 Be part of a rink hockey team competing in senior league (either local (third division/lower) or national (first and second division))\n\n * 2 Accept participating in the study (signing the informed consent)\n\nExclusion Criteria:\n\n* #1 not playing rink hockey in the previous season\n\n * 2 serious illness, injury or surgery in the previous 6 months that prevented rink hockey participation'}, 'identificationModule': {'nctId': 'NCT05994469', 'briefTitle': 'Prevention of Groin Injuries in Rink Hockey', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Prevention of Groin Injuries in Rink Hockey: A One Season Natural Experiment', 'orgStudyIdInfo': {'id': 'UO2023/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Copenhagen Adduction Exercise Group', 'description': 'there is no control group, all teams can implement the intervention protocol that better fits their normal schedule, the intervention can consist of 1 or 2 Copenhagen Adduction Exercise sessions per week', 'interventionNames': ['Behavioral: Copenhagen Adduction Exercise']}], 'interventions': [{'name': 'Copenhagen Adduction Exercise', 'type': 'BEHAVIORAL', 'description': 'The CAE is performed by side-lying on the floor with the dominant lower limb supported in the air by a teammate, the hip is adducted until the body forms a straight line from the ankles to the shoulders (concentric phase), then the player is instructed to lower the body slowly (eccentric phase) until reaching the floor to start the next repetition.', 'armGroupLabels': ['Copenhagen Adduction Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hugo Olmedillas', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hugo Olmedillas Fernandez', 'investigatorAffiliation': 'University of Oviedo'}}}}