Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02000492
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2013-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequent Ballgames Training for 9-11 Year Old Schoolchildren
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012420', 'term': 'Running'}, {'id': 'D065327', 'term': 'Circuit-Based Exercise'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 423}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Social effects', 'timeFrame': '1 Year', 'description': 'focus group Interviews'}], 'primaryOutcomes': [{'measure': 'Cardiac function', 'timeFrame': '1 year', 'description': 'echocardiography'}, {'measure': 'Body composition', 'timeFrame': '1 year', 'description': 'dual energy x-ray absorptiometry (DXA-scanning)'}], 'secondaryOutcomes': [{'measure': 'Cognitive effect', 'timeFrame': '1 year', 'description': 'computer based tests for cognitive and learning effects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Body Composition', 'Echocardiography']}, 'referencesModule': {'references': [{'pmid': '32497586', 'type': 'DERIVED', 'citation': 'Larsen MN, Madsen M, Nielsen CM, Manniche V, Hansen L, Bangsbo J, Krustrup P, Hansen PR. Cardiovascular adaptations after 10 months of daily 12-min bouts of intense school-based physical training for 8-10-year-old children. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):813-817. doi: 10.1016/j.pcad.2020.05.011. Epub 2020 Jun 1.'}, {'pmid': '27297443', 'type': 'DERIVED', 'citation': 'Larsen MN, Nielsen CM, Helge EW, Madsen M, Manniche V, Hansen L, Hansen PR, Bangsbo J, Krustrup P. Positive effects on bone mineralisation and muscular fitness after 10 months of intense school-based physical training for children aged 8-10 years: the FIT FIRST randomised controlled trial. Br J Sports Med. 2018 Feb;52(4):254-260. doi: 10.1136/bjsports-2016-096219. Epub 2016 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'Inactivity among schoolchildren is a challenge to public health and for the municipality in particular. This study´s aim is to evaluate the cognitive and physical as well as social and fitness adaptations, and learning outcomes of short- and long term ball training for 9-11 years old girls and boys, and to determine to what extend the organisation (5x12 minutes og 3x40 minute a week) and type of training (ball games, circuit training or running) influence the magnitude of response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9-11 years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen\n\nExclusion Criteria:\n\n* Children with severe mental or physical disabilities'}, 'identificationModule': {'nctId': 'NCT02000492', 'briefTitle': 'Frequent Ballgames Training for 9-11 Year Old Schoolchildren', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Intense School Based Physical Activity - Physiological, Cognitive and Sociological Aspects', 'orgStudyIdInfo': {'id': 'H-3-2013-038'}, 'secondaryIdInfos': [{'id': '18172', 'type': 'OTHER', 'domain': 'Styrelsen for Forskning og Innovation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': 'Football, circuit training or running 5x12 minutes or 3x 40 minutes', 'interventionNames': ['Behavioral: Football', 'Behavioral: Running', 'Behavioral: Circuit training']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Football', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Training']}, {'name': 'Running', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Training']}, {'name': 'Circuit training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Frederikssund', 'state': 'Denmark', 'country': 'Denmark', 'facility': 'Municipality of Frederikssund', 'geoPoint': {'lat': 55.83956, 'lon': 12.06896}}], 'overallOfficials': [{'name': 'Peter Krustrup, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre of team sports and health, University of Copenhagen'}, {'name': 'Peter R Hansen, dr Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital og Gentofte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Municipal doktor', 'investigatorFullName': 'Claus Malta Nielsen', 'investigatorAffiliation': 'University of Copenhagen'}}}}