Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-06 @ 10:05 PM
Study NCT ID:
NCT03080792
Status:
TERMINATED
Last Update Posted:
2021-06-04
First Post:
2016-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Exercise for Allogeneic Stem Cell Transplant Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Recruitment difficult', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of supervised high-intensity aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer patients. Measured as adherence to the training protocol', 'timeFrame': '4-12 weeks', 'description': 'Adherence is defined as \\>50% of prescribed exercise sessions completed.'}, {'measure': 'Safety of supervised high-intensity exercise aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer', 'timeFrame': '4-12 weeks', 'description': 'Minor and Major adverse events that are related to the exercise intervention'}], 'secondaryOutcomes': [{'measure': 'Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer', 'timeFrame': '4-12 weeks'}, {'measure': 'Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT)', 'timeFrame': '4-12 weeks'}, {'measure': 'Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test', 'timeFrame': '4-12 weeks'}, {'measure': 'Change in maximal voluntary isometric hand-grip strength', 'timeFrame': '4-12 weeks'}, {'measure': 'Change in Quality of Life (QoL)', 'timeFrame': '4-12 weeks', 'description': 'European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)'}, {'measure': 'Change in Fatigue', 'timeFrame': '4-12 weeks', 'description': 'Multidimensional Fatigue Inventory, MFI 20'}, {'measure': 'Change in depression', 'timeFrame': '4-12 weeks', 'description': 'Center for Epidemiologic Studies Depression Scale, CES-D'}, {'measure': 'Body Composition', 'timeFrame': '4-12 weeks', 'description': 'Bioelectrical impendance analysis'}, {'measure': 'Estimate the number of eligible patients', 'timeFrame': '12 month'}, {'measure': 'Evaluation of recruitment procedures', 'timeFrame': '12 month', 'description': 'Description of possible recruiting procedures in the ambulatory and stationary setting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stem cell transplantation', 'exercise', 'high intensity interval training', 'resistance training', 'physical fitness', 'cancer'], 'conditions': ['Cancer, Hematological']}, 'descriptionModule': {'briefSummary': 'The PRESENT-P study is a one-arm exercise intervention study for hematological cancer patients prior allogeneic stem cell transplantation (allo-HCT). This pilot study will investigate in a prehabilitation approach the safety and feasibility of high-intensity exercise program directly prior transplantation.', 'detailedDescription': 'The major objective of PRESENT-P is to investigate the feasibility and safety of a high intensity endurance exercise training (HIIT) and progressive resistance exercise prior allo-HCT. This multicenter pilot study will include n=30 patients. Patients perform two supervised exercise sessions per week. Recruitment take place 6-12 weeks prior allogeneic stem cell transplantation. Further aims of this pilot study are: to estimate the number of eligible patients, evaluate the recruitment procedure, and to explore the effect of HIIT prior allo-HCT on maximal oxygen uptake (VO2peak),submaximal endurance capacity, muscle strength, patient-reported-outcomes including QoL and physical functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hematological cancer, e.g. AML, CLL, MM\n* Scheduled for allo-HCT at the University Clinic Heidelberg or other cooperation sites within the next 4-12 weeks\n* Patients ≥ 18 years of age\n* Sufficient German language skills\n* Willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing\n* Signed informed consent\n\nExclusion Criteria:\n\n* Heart insufficiency \\> NYHA III or uncertain arrhythmia\n* Uncontrolled hypertension\n* Severe renal dysfunction (GFR \\< 30%, Creatinine\\> 3mg/dl)\n* Reduced standing or walking ability\n* Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL)\n* Any other comorbidities that preclude participation in the exercise programs\n* Engaging in systematic intense exercise training (at least 1h twice per week)'}, 'identificationModule': {'nctId': 'NCT03080792', 'acronym': 'PRESENT-P', 'briefTitle': 'Pre-Exercise for Allogeneic Stem Cell Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Pre-Exercise for Allogeneic Stem Cell Transplant Patients: a Pilot Study', 'orgStudyIdInfo': {'id': 'PRESENT-P/ S-030/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Exercise Intervention, moderate to high-intensity endurance and resistance exercise', 'interventionNames': ['Behavioral: Experimental: moderate to high-intensity exercise']}], 'interventions': [{'name': 'Experimental: moderate to high-intensity exercise', 'type': 'BEHAVIORAL', 'description': '2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University of Colone', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'University Hospital Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60488', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'UCT Frankfurt / Hospital North-West', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Medical Center - University Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Heidelberg University Hospital', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Joachim Wiskemann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'University of Cologne', 'class': 'OTHER'}, {'name': 'University Hospital Dresden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Joachim Wiskemann', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}