Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT06356935
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Heavy-load Resistance Training
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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Explosive muscle strength', 'timeFrame': 'Eight week off-season', 'description': 'Rate of torque development - (Nm/s)/kg'}, {'measure': 'Acceleration capacity', 'timeFrame': 'Eight week off-season', 'description': 'Sprint performance - seconds'}, {'measure': 'Agility performance', 'timeFrame': 'Eight week off-season', 'description': 'Game-based agility performance - seconds'}, {'measure': 'Jump ability', 'timeFrame': 'Eight week off-season', 'description': 'Countermovement jump height - cm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance training', 'Agility performance', 'Jump capacity', 'Knee extensor and flexor strength', 'Explosive muscle strength', 'Sprint ability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON).", 'detailedDescription': "The study aims to examine how an eight-week heavy-load resistance training regimen affects both mechanical muscle function and functional performance in elite female team handball players. Given the sport's demands for rapid and forceful muscle actions, understanding the impact of such training on functional performance is crucial.\n\nPlayers from four clubs in the Danish Women's Handball League, will be randomly block randomized (one block=one club) into two groups: the heavy-load resistance training group (RT), and the control group (CON). Each group contains players from 2 clubs. The study will conduct a battery of tests to evaluate various aspects of mechanical muscle function and performance, including isometric knee extensor and flexor peak torque, countermovement jump (CMJ) power/work, and functional measures like sprinting, jump height, and agility performance."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Playing in the Danish Women's Handball League.\n\nExclusion Criteria:\n\n* Absent from team handball training for more than two weeks due to injuries, within the six months preceding PRE-testing."}, 'identificationModule': {'nctId': 'NCT06356935', 'briefTitle': 'Effects of Heavy-load Resistance Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Effects of Resistance Training on Lower Limb Mechanical Muscle Function and Sports Specific Performance in Elite Female Team Handball Players', 'orgStudyIdInfo': {'id': 'HP2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance training', 'description': 'Assigned to heavy-load undulating resistance training.', 'interventionNames': ['Other: RT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Training-as-usual off-season strength and conditioning training, programs provided by respective clubs', 'interventionNames': ['Other: CON']}], 'interventions': [{'name': 'RT', 'type': 'OTHER', 'description': 'Resistance training', 'armGroupLabels': ['Resistance training']}, {'name': 'CON', 'type': 'OTHER', 'description': 'Control group', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Bjørn Fristrup, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Team Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}