Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 1:07 PM
Study NCT ID:
NCT00883961
Status:
UNKNOWN
Last Update Posted:
2009-12-23
First Post:
2009-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Following Autologous Peripheral Blood Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-21', 'studyFirstSubmitDate': '2009-04-17', 'studyFirstSubmitQcDate': '2009-04-17', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2max', 'timeFrame': 'At recruitment and after 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Mood', 'timeFrame': 'At recruitment and after 3 weeks'}, {'measure': 'Duration of aplasia', 'timeFrame': '3 weeks'}, {'measure': 'Complications during hospitalization', 'timeFrame': '3 weeks'}, {'measure': 'Need for transfusion of platelets and red blood cells', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-dose chemotherapy', 'Hematological neoplasties', 'Fatigue', 'Cancer', 'Exercise', 'Sport', 'Hematologic neoplastic disorders'], 'conditions': ['Hematological Disease']}, 'descriptionModule': {'briefSummary': 'The study evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70\n* Hematological disease\n* Treatment with high-dose chemotherapy followed by autologous stem cell transplantation\n* Understanding of written German\n\nExclusion Criteria:\n\n* Cardiorespiratory, metabolical, osteoarticular or immunological diseases which can be aggravated by exercise\n* Pathological stress-ECG at admission'}, 'identificationModule': {'nctId': 'NCT00883961', 'briefTitle': 'Exercise Following Autologous Peripheral Blood Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'EA4/029/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised exercise', 'interventionNames': ['Other: Supervised exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The patients will not carry out a structured exercise program.'}], 'interventions': [{'name': 'Supervised exercise', 'type': 'OTHER', 'description': 'The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.', 'armGroupLabels': ['Supervised exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fernando Dimeo, MD', 'role': 'CONTACT'}, {'name': 'Fernando Dimeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Fernando Dimeo, MD', 'role': 'CONTACT', 'email': 'fernando.dimeo@charite.de', 'phone': '+493084452098'}], 'overallOfficials': [{'name': 'Fernando Dimeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Fernando Dimeo', 'oldOrganization': 'Dept. of Sports Medicine, Charité Universitätsmedizin Berlin'}}}}