Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04630951
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction Strength Training in Professional 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Muscle Mass', 'timeFrame': 'Change from Baseline in Muscle Mass at 6 Weeks', 'description': 'Muscle Mass mesured with measuring tape'}, {'measure': 'Change from Baseline in Maximum Voluntary Isometric Contraction (MVIC)', 'timeFrame': 'Change from Baseline in Maximum voluntary Isometric Contraction at 6 Weeks', 'description': 'MVIC mesured by Force Platform (Vald Performance, Brisbane, QLD)'}, {'measure': 'Change from Baseline in Electrical Muscle Activity', 'timeFrame': 'Change from Baseline in Electrical Muscle Activity at 6 weeks', 'description': 'Electrical Muscle Activity mesured by Surface Electromyography (mDurance®, España)'}, {'measure': 'Change from Baseline in Countermovement Jump (CMJ)', 'timeFrame': 'Change from Baseline in countermovement Jump (CMJ Test) at 6 weeks', 'description': 'CMJ Test measured by Force Platform (Vald Performance, Brisbane, QLD)'}, {'measure': 'Change from in Force-Velocity Profile (F-V)', 'timeFrame': 'Change from Baseline in Force-Velocity Profile at 6 Weeks', 'description': 'F-V Profile measured by MyJump App'}, {'measure': 'Change from Baseline in Sprint Ability', 'timeFrame': 'Change from Baseline in Sprint Ability at 6 weeks', 'description': 'Sprint Ability measured by MySprint App'}, {'measure': 'Change from Post-Intervention in Sport Injuries Incidence', 'timeFrame': 'Change from Post-Intervention up to 8 months.', 'description': 'Incidence of injuries related to sport practice'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Strenght Training', 'Soccer', 'Blood Flood Restriction', 'Performance', 'Sport Injuries'], 'conditions': ['Resistance Training', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The aims of this clinical study are evaluated the effects of Blood Flood Restriction training on the sport performance of professional and semi-professional soccer players. The participants are twenty male professional and semi-professional soccer players who are playing at RCD Mallorca. Participants will be assigned in two different groups. Both groups develop for six weeks a strength training programs. The first group will base their training in Low Load using Blood Flow Restriction (20-50% of one maximum repetition). The second group will base their training in High Load (60-80% of one maximum repetition). This training program includes three type of exercises in each training session; back squat, single deadlift and barbell hip thrust. Before and after this program the investigators will collect sociodemographic and anthropometrics data. On top of that, the investigators will evaluate the muscle mass, the electrical activity produced by skeletal muscles, the muscle strength and the sprint ability of every participant. Before to the evaluation, the soccer players will warm-up during 15 minutes under the control of the evaluators.', 'detailedDescription': 'PARTICIPANTS:\n\nParticipants are soccer players of RCD Mallorca (Second Spanish Football Division) and RCD Mallorca B (Third Spanish Football Division).Before to start the study, every participant will receive an informed consent about the clinical study. This informed consent will be signed by them according to Declaration of Helsinki. At the same time, the data will be anonymized and only the main researcher of the study will have access to it, to ensure compliance with the Data Protection Law.\n\nW-UP:\n\nThe warm-up will consist of 5 minutes running slow (treadmill), 5 minutes mobility, and 5 minutes of running exercises. In addition, the warm-up will contain a familiarization with the jump test'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No injuries in the last 6 months\n* 1 years experience minimun in the division.\n\nExclusion Criteria:\n\n* Amateurs players'}, 'identificationModule': {'nctId': 'NCT04630951', 'briefTitle': 'Blood Flow Restriction Strength Training in Professional Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'University of the Balearic Islands'}, 'officialTitle': 'Effects of Blood Flow Restriction Resistance Training on Muscle Characteristics, Strength and Performance of Professional Soccer Players', 'orgStudyIdInfo': {'id': '160CER20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strength training based on low loads with blood flow restriction (Experimental group I)', 'description': '1. Squat\n2. Single Deadlift\n3. Back Squat', 'interventionNames': ['Other: Blood Flow Restriction Strength training with low load']}, {'type': 'EXPERIMENTAL', 'label': 'Strenght training based on high loads (Experimental group II)', 'description': '1. Squat\n2. Single Deadlift\n3. Back Squat', 'interventionNames': ['Other: High Load Strength Training']}], 'interventions': [{'name': 'Blood Flow Restriction Strength training with low load', 'type': 'OTHER', 'description': 'Low Load (20-50% 1RM), 4 set of 30/15/15/15 repetitions, 30 seconds resting between sets.', 'armGroupLabels': ['Strength training based on low loads with blood flow restriction (Experimental group I)']}, {'name': 'High Load Strength Training', 'type': 'OTHER', 'description': 'High Load (60-80% 1RM) 4 sets of 8 repetitions, 2 minutes resting between sets', 'armGroupLabels': ['Strenght training based on high loads (Experimental group II)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07122', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Christian', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Natalia Romero Franco', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Balearic Islands'}, {'name': 'Christian Castilla López', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Balearic Islands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Balearic Islands', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}