Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 11:07 AM
Study NCT ID:
NCT03862560
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Physical Performance and Functional Asymmetries in Female Football
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-02', 'studyFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-03-02', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Jumping in centimeters', 'timeFrame': 'Change from baseline in jumping height at 12 weeks', 'description': 'Jumping height was assessed using a vertical countermovement jump, drop jump and standing broad jump with flight.'}, {'measure': 'Velocity in seconds', 'timeFrame': 'Change from baseline in velocity at 12 weeks', 'description': 'Running speed was evaluated by a 40-m sprint time (standing start) with 10-m, 20-m, 30-m split times.'}, {'measure': 'Change of direction in seconds', 'timeFrame': 'Change from Baseline in change of direction at 12 weeks', 'description': 'Change of direction ability was assessed by 180º change of direction and V-cut tests.'}, {'measure': 'Inter-limb asymmetry in %', 'timeFrame': 'Change from Baseline in inter-limb asymmetry at 12 weeks', 'description': 'Inter-limb asymmetry was calculated using the following formula : Inter-limb asymmetry = 100/Max Value (right and left)\\*Min Value (right and left)\\*-1+100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Soccer', 'Female', 'Lower limb asymmetries', 'Strength'], 'conditions': ['Resistance Training', 'Inter-limb Asymmetries', 'Athletic Performance']}, 'referencesModule': {'references': [{'pmid': '14987126', 'type': 'RESULT', 'citation': 'Hoff J, Helgerud J. Endurance and strength training for soccer players: physiological considerations. Sports Med. 2004;34(3):165-80. doi: 10.2165/00007256-200434030-00003.'}, {'pmid': '15699058', 'type': 'RESULT', 'citation': 'Olsen OE, Myklebust G, Engebretsen L, Holme I, Bahr R. Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial. BMJ. 2005 Feb 26;330(7489):449. doi: 10.1136/bmj.38330.632801.8F. Epub 2005 Feb 7.'}, {'pmid': '23772338', 'type': 'RESULT', 'citation': 'Brumitt J, Heiderscheit BC, Manske RC, Niemuth PE, Rauh MJ. Lower extremity functional tests and risk of injury in division iii collegiate athletes. Int J Sports Phys Ther. 2013 Jun;8(3):216-27.'}, {'pmid': '20065198', 'type': 'RESULT', 'citation': 'Kiani A, Hellquist E, Ahlqvist K, Gedeborg R, Michaelsson K, Byberg L. Prevention of soccer-related knee injuries in teenaged girls. Arch Intern Med. 2010 Jan 11;170(1):43-9. doi: 10.1001/archinternmed.2009.289.'}]}, 'descriptionModule': {'briefSummary': 'Worldwide, soccer has grown increasingly popular among female players. According to the Women´s Football Survey of the Fédération Internationale de Football Association (FIFA), there were more than 30 million registered women soccer players in 2014. Elite female soccer players cover approximately a total distance of 10 km with 1.7 km completed at high-speed (\\>18 km/h-1), between 1350 and 1650 changes of activity like passing, dribbling, tackling and trapping and 5.1 and 31.2 repeated sprinting and high intensity bouts, respectively. Thus, it seems that those strategies addressed to improve such high-intensity activities should be considered a priority for female soccer players.\n\nDifferent training methods to improve soccer specific variables have been developed such as, high-intensity interval training, resisted sprint training, strength training or plyometric training. Whilst individual training interventions have been shown to produce enhancements in measures of athletic performance for soccer players, there is a paucity of studies looking at the effectiveness of strength and power training specifically on performance measures in female soccer populations.\n\nUnilateral strength asymmetry can be a risk factor of musculoskeletal injuries. In recent years, inter-limb asymmetries have been included in battery tests performed by different soccer clubs due to their relation with lower-limb injuries. Few studies have analysed the change of an intervention on inter-limb asymmetry in female soccer players, hence, more studies for this population are warranted.\n\nThe main aim of this research project is therefore, to evaluate the effect of a physical intervention on the performance and inter-limb asymmetries of female soccer players.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian, Healthy participant, from 12 to 20 years old, with a history of training at least 3 years.\n\nExclusion Criteria:\n\n* Non-caucasian, injury.'}, 'identificationModule': {'nctId': 'NCT03862560', 'briefTitle': 'Evaluation of Physical Performance and Functional Asymmetries in Female Football', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Evaluación Del Rendimiento físico y asimetrías Funcionales en el fútbol Femenino', 'orgStudyIdInfo': {'id': 'C.P. - C.I. PI19/039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Female soccers that perform a strength training', 'interventionNames': ['Other: Strength training program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Female soccers that do not perform a strength training'}], 'interventions': [{'name': 'Strength training program', 'type': 'OTHER', 'description': 'Strength training program in female soccer players', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zaragoza', 'country': 'Spain', 'facility': 'GENUD Research group (Growth, Exercise, NUtrition and Development)', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'José A. Casajús', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}