Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00839904
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2009-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Activity and Health of Children With Cancer in Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2009-02-08', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '6months'}, {'measure': 'mood', 'timeFrame': '6months'}, {'measure': 'cardiorespiratory fitness', 'timeFrame': '6months'}, {'measure': 'body fat percentage', 'timeFrame': '6months'}, {'measure': 'bone mineral density', 'timeFrame': '6months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children', 'cancer', 'exercise', 'fitness', 'body composition'], 'conditions': ['Children', 'Cancer', 'Exercise']}, 'descriptionModule': {'briefSummary': 'Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children aged 6-16\n* remission from cancer\n* \\>6 months after completion of all therapy\n\nExclusion Criteria:\n\n* informed consent not given in writing\n* refusal of tests: blood, fitness, questionnaires or DEXA\n* locomotive handicaps\n* extreme fatigue, nausea, dyspnea\n* concurrent acute illness\n* recent (less than 3 months) hospitalization\n* documented (echocardiographic or nuclear medicine) decrease in cardiac function\n* abnormal blood tests: Hb \\< 10 gr/dl, neutropenia \\< 500/mm3, thrombocytopenia \\< 50,000/mm3\n* additional chronic health conditions unrelated to cancer (e.g. celiac disease, cerebral palsy, Down's syndrome)"}, 'identificationModule': {'nctId': 'NCT00839904', 'briefTitle': 'Physical Activity and Health of Children With Cancer in Remission', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission', 'orgStudyIdInfo': {'id': 'GDR2-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise', 'description': 'two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day', 'interventionNames': ['Behavioral: exercise']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no intervention'}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day', 'armGroupLabels': ['exercise']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Israel Cancer Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior physician', 'investigatorFullName': 'gal dubnov raz', 'investigatorAffiliation': 'Sheba Medical Center'}}}}