Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-03-04 @ 10:23 AM
Study NCT ID:
NCT04673903
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Copenhagen Adduction Exercise on Groin Injuries Rate Among Soccer Players.
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 Copenhagen adduction exercise into their 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': '2021-07-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-12', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-12', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', '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.\n\nData will be collected from Sports Injury Tracker injury reporting form. Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia).\n\nInjury 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.\n\nData will be collected from Sports Injury Tracker injury reporting form.'}], '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 using attendance log.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Copenhagen Adduction Exercise', 'Groin injuries', 'Soccer'], 'conditions': ['Groin Injuries']}, 'referencesModule': {'references': [{'pmid': '26589483', 'type': 'BACKGROUND', 'citation': 'Ishoi L, Sorensen CN, Kaae NM, Jorgensen LB, Holmich P, Serner A. Large eccentric strength increase using the Copenhagen Adduction exercise in football: A randomized controlled trial. Scand J Med Sci Sports. 2016 Nov;26(11):1334-1342. doi: 10.1111/sms.12585. Epub 2015 Nov 21.'}, {'pmid': '29891614', 'type': 'BACKGROUND', 'citation': 'Haroy J, Clarsen B, Wiger EG, Oyen MG, Serner A, Thorborg K, Holmich P, Andersen TE, Bahr R. The Adductor Strengthening Programme prevents groin problems among male football players: a cluster-randomised controlled trial. Br J Sports Med. 2019 Feb;53(3):150-157. doi: 10.1136/bjsports-2017-098937. Epub 2018 Jun 10.'}, {'pmid': '9989713', 'type': 'BACKGROUND', 'citation': 'Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.'}, {'pmid': '26621401', 'type': 'BACKGROUND', 'citation': 'Holmich P. Groin injuries in athletes--development of clinical entities, treatment, and prevention. Dan Med J. 2015 Dec;62(12):B5184.'}, {'pmid': '28806100', 'type': 'BACKGROUND', 'citation': 'Haroy J, Thorborg K, Serner A, Bjorkheim A, Rolstad LE, Holmich P, Bahr R, Andersen TE. Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial. Am J Sports Med. 2017 Nov;45(13):3052-3059. doi: 10.1177/0363546517720194. Epub 2017 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The effect of the Copenhagen Adduction Exercise on groin injuries rate among soccer players The Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip Adductors. It has a large eccentric component, meaning the muscles are working whilst lengthening.\n\nThe purpose of this study is to investigate the effect of the Copenhagen adduction exercise on groin injuries among soccer players.\n\nIt hypothesized that Copenhagen adduction exercise has a beneficial effect in terms of groin injury prevention.', 'detailedDescription': "Study type Interventional Description of intervention(s) / exposure The intervention group will be instructed to include the Copenhagen adduction exercise into their 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\nThe Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip adductor. It has a large eccentric component, meaning the muscles are working whilst lengthening.\n\nThe Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch.\n\nThe Copenhagen Adduction exercise requires a partner who will hold the player's upper leg in an extended position nearly at the hip level of the partner, with one hand supporting the knee and the other upholding the ankle. Meanwhile, the player will lie on one side and support the body with the forearm on the ground and the top arm being placed along the body. Then, the player will elevate the trunk from the floor and raise the lower leg in a straight line. The player will repeat this for 3 seconds until the feet touch each other. This will be followed by slightly lowering the body just to the ground for 3 seconds until it touches the level of the foot.\n\nIt must be performed on both limbs. It is crucial to note that the most accurate performance of the exercise must avoid trunk bending. In terms of the training form, the frequency is three-two sessions per week while the repetition varies according to the different levels of the players ranging from 3-12 times in one-two sets.\n\nPrevention Comparator / control treatment 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSoccer teams Amateur. Male . Training at least three times per week.\n\nExclusion Criteria:\n\nHistory of lower extremity injury requiring medical attention in the past 6 months, or systemic diseases, cardiovascular disease, neurological disorders or bone fractures or surgery in the previous year.\n\nPlayers who joined a participating team after the start of the trial will be excluded.'}, 'identificationModule': {'nctId': 'NCT04673903', 'briefTitle': 'The Effect of the Copenhagen Adduction Exercise on Groin Injuries Rate Among Soccer Players.', 'organization': {'class': 'OTHER', 'fullName': 'Umm Al-Qura University'}, 'officialTitle': 'The Effect of the Copenhagen Adduction Exercise on Groin Injuries Rate Among Soccer Players. A Cluster Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'HAPO-02-K-012-2020-11-481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group will be instructed to include the Copenhagen adduction exercise into their warm up before training session (3 times per week) during one season (6 months).\n\nThe Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip adductor. It has a large eccentric component, meaning the muscles are working whilst lengthening.', 'interventionNames': ['Other: Copenhagen adduction exercise']}, {'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': 'Copenhagen adduction exercise', 'type': 'OTHER', 'description': "The Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch.", '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 for 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'}}}}