Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT02228603
Status:
COMPLETED
Last Update Posted:
2019-08-30
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise as a Life-long Medicine in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in peak oxygen uptake', 'timeFrame': '2 years', 'description': 'measured during exercise on treadmill (MetaMax Cortex/Innocor)'}], 'secondaryOutcomes': [{'measure': 'physical activity', 'timeFrame': '2 years', 'description': 'assessed by accelerometer SenseWear Armband Pro'}, {'measure': 'quality of life', 'timeFrame': '2 years', 'description': 'assessed by MacNew Health-related quality of life questionnaire'}, {'measure': 'depression', 'timeFrame': '2 years', 'description': 'assessed by Hospital anxiety and depression scale (HAD)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise therapy', 'rehabilitation'], 'conditions': ['Cardiovascular Diseases', 'Myocardial Infarction', 'Angina (Stable)']}, 'descriptionModule': {'briefSummary': 'Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.\n\nThe aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* myocardial infarction, stable angina, heart surgery\n* finished phase 2 cardiac rehabilitation\n* clinically stable\n* able to communicate in Norwegian\n* able to do a maximal treadmill test\n\nExclusion Criteria:\n\n* unstable angina\n* serious cardiac arrhythmia\n* serious heart valve insufficiency\n* heart failure\n* any contraindication for high intensity exercise training\n* participation in other exercise study\n* pregnancy\n* cognitive impairment\n* drug abuse'}, 'identificationModule': {'nctId': 'NCT02228603', 'briefTitle': 'Exercise as a Life-long Medicine in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs', 'orgStudyIdInfo': {'id': '2014/92'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high-intensity exercise', 'description': 'community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months', 'interventionNames': ['Behavioral: high-intensity exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'web-based follow-up', 'description': 'web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months', 'interventionNames': ['Behavioral: web-based follow-up program']}, {'type': 'OTHER', 'label': 'control', 'description': 'control group will receive usual care: information about recommended physical activity and healthy lifestyle', 'interventionNames': ['Behavioral: usual care']}], 'interventions': [{'name': 'high-intensity exercise training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['high-intensity exercise']}, {'name': 'web-based follow-up program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['web-based follow-up']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Levanger', 'country': 'Norway', 'facility': 'Levanger Hospital', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Asbjørn Støylen, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}