Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-03 @ 4:52 AM
Study NCT ID:
NCT01748058
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2012-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Video Games to Promote Physical Activity in Children With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-19', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accelerometer, average counts of dynamic acceleration (physical activity)', 'timeFrame': '1 week at baseline and at 12 months', 'description': "Change in the children's physical activity levels with accelerometer"}], 'secondaryOutcomes': [{'measure': 'Movement assessment battery for children (M-ABC-2) scores (motor performance)', 'timeFrame': 'At baseline, 2, 6, 12 and 24 months', 'description': 'Change in M-ABC scores'}, {'measure': 'PedsQL Multidimensional Fatigue Scale scores (fatigue)', 'timeFrame': 'At baseline, 2, 6, 12 and 24 months', 'description': 'Change in experienced fatigue'}, {'measure': 'Blood sugar', 'timeFrame': 'At baseline, 2, 6, 12 and 24 months', 'description': 'Change in blood sugar'}, {'measure': 'Blood insulin', 'timeFrame': 'At baseline, 2, 6, 12 and 24 months', 'description': 'Change in blood insulin'}]}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '31783907', 'type': 'DERIVED', 'citation': 'Hamari L, Jarvela LS, Lahteenmaki PM, Arola M, Axelin A, Vahlberg T, Salantera S. The effect of an active video game intervention on physical activity, motor performance, and fatigue in children with cancer: a randomized controlled trial. BMC Res Notes. 2019 Nov 29;12(1):784. doi: 10.1186/s13104-019-4821-z.'}, {'pmid': '24708773', 'type': 'DERIVED', 'citation': 'Kauhanen L, Jarvela L, Lahteenmaki PM, Arola M, Heinonen OJ, Axelin A, Lilius J, Vahlberg T, Salantera S. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. BMC Pediatr. 2014 Apr 5;14:94. doi: 10.1186/1471-2431-14-94.'}], 'seeAlsoLinks': [{'url': 'http://www.biomedcentral.com/1471-2431/14/94', 'label': 'Study protocol'}, {'url': 'https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-019-4821-z', 'label': 'Results'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy and feasibility of active video gaming with regard to the promotion of physical activity and motor learning in children with cancer. Experienced fatigue, body mass index and the development of metabolic risk factors during treatment are also examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cancer diagnose\n* treated with Vincristine in Turku University Hospital or Tampere University Hospital\n\nExclusion Criteria:\n\n* other diseases limiting functional ability\n* not able to communicate'}, 'identificationModule': {'nctId': 'NCT01748058', 'briefTitle': 'Active Video Games to Promote Physical Activity in Children With Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Active Video Games to Promote Physical Activity, Motor Performance and Quality of Life in Children With Cancer: an Intervention Study With 2-year Follow-up', 'orgStudyIdInfo': {'id': 'T87/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active video games', 'description': 'Exercise based on active video gaming', 'interventionNames': ['Behavioral: Exercise based on active video gaming']}, {'type': 'NO_INTERVENTION', 'label': 'Routine care'}], 'interventions': [{'name': 'Exercise based on active video gaming', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Active video games']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Päivi Lähteenmäki', 'investigatorAffiliation': 'Turku University Hospital'}}}}