Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 1:50 AM
Study NCT ID:
NCT01575704
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2012-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Exercise Therapy in Pediatric Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-31', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-04-10', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation', 'description': 'Upper limb: hand grip strength with JAMAR dynamometry; Lower limb: maximal isometric voluntary strength of M. quadriceps femoris'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation', 'description': 'Pediatric Quality of Life Inventory (PedsQL)'}, {'measure': 'Biomarker in blood', 'timeFrame': 'daily', 'description': 'Hematological and immunological reconstitution'}, {'measure': 'Body composition', 'timeFrame': 'one time per week and change between 3 months and 6 months after transplantation', 'description': 'Bioelectrical Impedance Analyse (BIA; Data Input GmbH)'}, {'measure': 'Endurance performance', 'timeFrame': 'change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation', 'description': '6-Minute-Walking-Test (6MWT); Ergospirometry and Echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise', 'Hematopoetic cell transplantation', 'Children'], 'conditions': ['Hematopoetic Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '31089282', 'type': 'DERIVED', 'citation': 'Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents.\n\nThe main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for hsct\n* Informed consent signed\n\nExclusion Criteria:\n\n* Contraindication for exercise\n* Age \\< 5 years\n* Insuperable language barrier\n* Orthopeadical, cardiological or neurological indication for physical therapy'}, 'identificationModule': {'nctId': 'NCT01575704', 'acronym': 'BISON', 'briefTitle': 'Physical Exercise Therapy in Pediatric Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)', 'orgStudyIdInfo': {'id': 'BISON01042011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sport', 'interventionNames': ['Other: Exercise']}, {'type': 'OTHER', 'label': 'Control', 'interventionNames': ['Other: Mental Training']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Supervised exercise training (aerobic, resistance, flexibility), 5 times per week', 'armGroupLabels': ['Sport']}, {'name': 'Mental Training', 'type': 'OTHER', 'description': 'Memorial/ mental training and relaxation, 5 times per week', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut für Sportwissenschaften, Frankfurt', 'class': 'UNKNOWN'}, {'name': 'Fresenius University of Applied Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Department of Stem Cell Transplantation and Immunology', 'investigatorFullName': 'Peter Bader', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}