Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-28 @ 4:04 PM
Study NCT ID:
NCT05281250
Status:
WITHDRAWN
Last Update Posted:
2022-03-16
First Post:
2018-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Physical Exercise to Prevent Functional Deterioration During Hospitalization (EFFAPRO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'structural change at the hospital', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-04', 'studyFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional capacity', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'Functional Independence Measure (FIM)'}], 'secondaryOutcomes': [{'measure': 'Strength', 'timeFrame': 'Through study completion (average 10 days).', 'description': 'Dynamometry'}, {'measure': 'Cardiorespiratory condition', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'Six minute test .'}, {'measure': 'Daily physical activity', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'Accelerometry during the hospitalization.'}, {'measure': 'Fatigue-FACIT', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'FACIT Fatigue Scale'}, {'measure': 'Fatigue-PERFORM', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'PERFORM Fatigue questionnaire (12-60) Higher, better (less fatigue)'}, {'measure': 'Life quality: Q30 questionnaire', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'QLQ30 questionnaire (quality of life). 0-100 (HIGHER, better)'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Through study completion (average 10 days)', 'description': 'HADS questionnaire (anxiety and depression). 0-42 (less better)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Through study completion (average 10 days).', 'description': 'Number of days the patient is hospitalized.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'physical activity', 'Physical condition'], 'conditions': ['Cancer Patients', 'Hospitalized']}, 'descriptionModule': {'briefSummary': 'This is a randomized study that will measure the possible benefit of supervised training during the hospitalization of patients with stage IV neoplasms in active treatment.', 'detailedDescription': 'The trial is not going to be runned'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stage IV neoplasms.\n* Active treatment: chemotherapy, hormone therapy, immunotherapy or targeted therapies.\n* Hospitalization at Medical Oncology Departmentof the Hospital Puerta de Hierro.\n* Reason for hospitalization is expected to be solved in less than two weeks.\n\nExclusion Criteria:\n\n* Patients who do not wish to participate.\n* Cognitive impairment.\n* Hospitalization due to progression of oncological disease.\n* Acute coronary syndrome or bone fracture in limbs during the previous three months.'}, 'identificationModule': {'nctId': 'NCT05281250', 'acronym': 'EFFAPRO', 'briefTitle': 'Evaluation of Physical Exercise to Prevent Functional Deterioration During Hospitalization (EFFAPRO)', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Evaluation of Physical Exercise as a Protective Factor for the Loss of Functional Capacity in Patients With Metastatic Tumors During Hospitalization. Pilot Study (EFFAPRO)', 'orgStudyIdInfo': {'id': 'PH-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised physical exercise', 'description': 'Supervised exercise (aerobic + strength + flexibility) depending on the functional capacity of each patient, during hospitalization', 'interventionNames': ['Other: Supervised physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will receive recommendations about exercising during hospitalization.'}], 'interventions': [{'name': 'Supervised physical exercise', 'type': 'OTHER', 'description': 'A supervised exercise is randomized. Although this intervention is not standard in our setting, it is a recommended practice, since it is known that rehabilitation strategies in hospitalized patients have different benefits.', 'armGroupLabels': ['Supervised physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}], 'overallOfficials': [{'name': 'Ana Ruiz Casado', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Puerta de Hierro University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Oncologist', 'investigatorFullName': 'Ana Ruiz-Casado', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}