Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT00856102
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2009-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive-psychosocial functions', 'timeFrame': '3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22846379', 'type': 'DERIVED', 'citation': 'Lee CE, Kilgour A, Lau YK. Efficacy of walking exercise in promoting cognitive-psychosocial functions in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Jul 30;12:324. doi: 10.1186/1471-2407-12-324.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.\n\nHypothesis:'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men aged 50 or older\n* diagnosed with adenocarcinoma prostate cancer\n* will initiate and receive continuous ADT (LHRH or combination of LHRH and anti-androgen for at least 6 months\n\nExclusion Criteria:\n\n* severe cardiac disease (New York Heart Association class III or greater)\n* angina\n* severe osteoporosis\n* uncontrolled hypertension\n* orthostastic blood pressure drop \\> 20mm Hg\n* moderate to severe aortic stenosis\n* acute illness or fever\n* uncontrolled atrial or ventricular dysrhythmias\n* uncontrolled sinus tachycardia (\\> 120 beats per minute)\n* uncontrolled congestive heart failure\n* third-degree atrio-ventricular heart block\n* active pericarditis or myocarditis\n* recent embolism, thrombophlebitis\n* deep vein thrombosis, resting ST displacement\n* uncontrolled diabetes\n* uncontrolled pain\n* cognitive impairment\n* history of falls due to balance impairment or lost of consciousness\n* severe neuromusculoskeletal conditions that limit their ability to perform walking exercise'}, 'identificationModule': {'nctId': 'NCT00856102', 'briefTitle': 'Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy', 'orgStudyIdInfo': {'id': 'H2008:318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Home-base walking program', 'armGroupLabels': ['Exercise']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Usual care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 0T6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Sciences Centre Foundation, Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'C. Ellen Lee,', 'oldOrganization': 'University of Manitoba'}}}}