Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT02249260
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2014-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-22', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Systolic and diastolic Blood Pressure', 'timeFrame': 'baseline, 12 weeks', 'description': 'Changes from baseline in systolic and diastolic blood pressure at 12 weeks'}], 'primaryOutcomes': [{'measure': 'Change in peak oxygen uptake', 'timeFrame': 'baseline, 15 months', 'description': 'Change from baseline in peak oxygen uptake at 15 months'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'baseline, 12 weeks', 'description': 'Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks'}, {'measure': 'Peak oxygen uptake', 'timeFrame': 'baseline, 12 weeks', 'description': 'Change from baseline in peak oxygen uptake at 12 weeks'}, {'measure': 'Time to exhaustion', 'timeFrame': 'baseline, 15 months', 'description': 'Change from baseline in "time to exhaustion" at 15 months'}, {'measure': 'Time to exhaustion', 'timeFrame': 'baseline, 12 weeks', 'description': 'Change from baseline in time to exhaustion at 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise, cardiac rehabilitation, quality of life'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation.\n\nSecondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.', 'detailedDescription': 'A prospective cohort study including all cardiac patients referred for outpatient cardiac rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation. HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable coronary heart disease\n* valvular surgery\n* refered to high-intensity exercise training from a cardiologist\n\nExclusion Criteria:\n\n* acute myocardial infarction within four week\n* serious rhythm disturbances\n* unstable angina pectoris\n* known significant comorbidity\n* symptomatic peripheral vascular disease\n* obstructive pulmonary disease with forced expiratory vital capacity \\< 60% of predicted\n* left ventricular ejection fraction \\< 40%'}, 'identificationModule': {'nctId': 'NCT02249260', 'acronym': 'OsloHeartEx', 'briefTitle': 'A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Long-term Follow up of Exercise Based Cardiac Rehabilitation in Oslo', 'orgStudyIdInfo': {'id': '2011/553 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral', 'description': 'Group-based high intensity interval training and lifestyle counseling', 'interventionNames': ['Behavioral: High intensity interval training']}], 'interventions': [{'name': 'High intensity interval training', 'type': 'BEHAVIORAL', 'otherNames': ['The Norwegian Ullevaal model'], 'description': 'Group-based high-intensity aerobic interval training and lifestyle counseling', 'armGroupLabels': ['Behavioral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0805', 'city': 'Oslo', 'state': 'Oslo County', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Birgitta B Nilsson, PhD', 'role': 'CONTACT', 'email': 'b.b.nilsson@medisin.uio.no', 'phone': '+47 93210913'}, {'name': 'Birgitta B Nilsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Norwegian Sport Clinic (NIMI)', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Birgitta B Nilsson, PhD', 'role': 'CONTACT', 'email': 'b.b.nilsson@medisin.uio.no', 'phone': '+4793210913'}, {'name': 'Helge Grimnes, MsC', 'role': 'CONTACT', 'email': 'helge.grimnes@oslo-universitetssykehus.no', 'phone': '+4723015052'}], 'overallOfficials': [{'name': 'Birgitta B Nilsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc', 'investigatorFullName': 'Birgitta Blakstad Nilsson, PhD', 'investigatorAffiliation': 'Oslo University Hospital'}}}}