Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 6:09 PM
Study NCT ID:
NCT01038960
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2009-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapy delivered from ICD, Anxiety score, functional status', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'HRV, Endothelial function', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ICD, training'], 'conditions': ['Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.', 'detailedDescription': 'ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD\n\nExclusion Criteria:\n\n* Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,'}, 'identificationModule': {'nctId': 'NCT01038960', 'acronym': 'ETHIC', 'briefTitle': 'Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Stavanger HF'}, 'officialTitle': 'Exercise Training to Reduce Ventricular Arrhythmia in Heart Failure Patients With ICD - The Ethic Study', 'orgStudyIdInfo': {'id': 'ETHIC-SUS-AIL-09'}, 'secondaryIdInfos': [{'id': '068.08', 'type': 'REGISTRY', 'domain': 'Norwegian Social Science Data Services'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise training', 'description': 'training', 'interventionNames': ['Behavioral: Exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Not training', 'description': 'No organized training'}], 'interventions': [{'name': 'Exercise training', 'type': 'BEHAVIORAL', 'otherNames': ['ICD, exercise training'], 'description': '3 months supervised interval training', 'armGroupLabels': ['Exercise training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger Health Research', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Alf Inge Larsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Stavanger Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}