Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-24 @ 4:37 PM
Study NCT ID:
NCT02602457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-04-26
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-10', 'releaseDate': '2023-12-04'}], 'estimatedResultsFirstSubmitDate': '2023-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life as measured by the Short-Form 36 questionnaire', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in quality of life from baseline to 12 weeks as measured by the Short Form-36 questionnaire.'}, {'measure': 'Change in exercise capacity as measured by six-minute walk test distance', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in exercise capacity from baseline to 12 weeks as measured by six-minute walk test distance.'}], 'secondaryOutcomes': [{'measure': 'Change in exercise adherence measured by accelerometer', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in exercise adherence from baseline to 12 weeks as measured by accelerometer.'}, {'measure': 'Change in activity status measured by the Duke Activity Status Index', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in activity status from baseline to 12 weeks as measured by the Duke Activity Status Index.'}, {'measure': 'Change in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in symptom burden from baseline to 12 weeks as measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale.'}, {'measure': 'Change in symptom frequency and severity measured using the 7-day symptom diary', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in symptom frequency and severity from baseline to 12 weeks as measured using the the 7-day symptom diary.'}, {'measure': 'Change in disease specific quality of life will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS)', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in disease specific quality of life from baseline to 12 weeks will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS).'}, {'measure': 'Change in anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in anxiety and depressive symptoms from baseline to 12 weeks will be measured using the Hospital Anxiety and Depression Scale (HADS).'}, {'measure': 'Change in sleep apnea risk will be measured by the STOP-BANG Sleep Apnea Questionnaire', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in risk of sleep apnea from baseline to 12 weeks will be measured by the STOP-BANG Sleep Apnea Questionnaire.'}, {'measure': 'Insomnia severity index will be measured using the Insomnia Severity Index', 'timeFrame': 'baseline to 12 weeks', 'description': 'Insomnia severity index at baseline and 12 weeks will be measured using the Insomnia Severity Index.'}, {'measure': 'Change in self reported sleep patterns will be measured using a 7-day sleep diary', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in self reported sleep patterns from baseline to 12 weeks will be measured using a 7-day sleep diary.'}, {'measure': 'Change in heart rate control will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in heart rate control from baseline to 12 weeks will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)'}, {'measure': 'Change in muscular fitness will be measured using standard load tests', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in muscular fitness from baseline to 12 weeks will be measured using standard load tests.'}, {'measure': 'Change in exercise capacity will be measured using a cardiopulmonary exercise test (CPET)', 'timeFrame': 'baseline to 12 weeks', 'description': 'Change in exercise capacity from baseline to 12 weeks will be measured using a cardiopulmonary exercise test (CPET)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '36315143', 'type': 'DERIVED', 'citation': "Reed JL, Terada T, Vidal-Almela S, Tulloch HE, Mistura M, Birnie DH, Wells GA, Nair GM, Hans H, Way KL, Chirico D, O'Neill CD, Pipe AL. Effect of High-Intensity Interval Training in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2239380. doi: 10.1001/jamanetworkopen.2022.39380."}]}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation is the most common heart rhythm disorder. The management of atrial fibrillation is of great importance. Despite the presence of exercise intolerance, weight gain, and an associated decline in overall health and well-being in patients living with atrial fibrillation, recommended standard care does not currently include the prescription of exercise to address these significant health issues. Exercise training is a recognized form of treatment of persons with heart disease. An exercise program such as high-intensity interval training when compared to moderate-intensity continuous exercise training may provide a stronger training stimulus for exercise and clinical outcomes; may be more efficient and motivating; and, may help to improve adherence to exercise training in persistent or permanent atrial fibrillation patients. This has been shown in patients with coronary artery disease and heart failure.\n\nThe primary objectives of this prospective study are to examine the impact of high-intensity interval training compared to moderate-intensity continuous exercise training in adults with persistent or permanent atrial fibrillation on exercise capacity and quality of life.', 'detailedDescription': 'Atrial fibrillation is the most common heart rhythm disorder. Significant disease and death rates are associated with atrial fibrillation because of stroke risk, the complications of medications, poor quality of life and reduced exercise tolerance. Many patients report they have a lower quality of life because of this condition, so finding new ways of helping patients manage and cope with this health problem may help a great number of people. The management of atrial fibrillation is of great importance. Despite the presence of exercise intolerance, weight gain, and an associated decline in overall health and well-being in patients living with atrial fibrillation, recommended standard care does not currently include the prescription of exercise to address these significant health issues. Exercise training is a recognized form of treatment of persons with heart disease. An exercise program such as high-intensity interval training when compared to moderate-intensity continuous exercise training may provide a stronger training stimulus for exercise and clinical outcomes; may be more efficient and motivating; and, may help to improve adherence to exercise training in persistent or permanent atrial fibrillation patients. This has been shown in patients with coronary artery disease and heart failure.\n\nThe primary objectives of this prospective study are to examine the impact of high-intensity interval training compared to moderate-intensity continuous exercise training in adults with persistent or permanent atrial fibrillation on exercise capacity and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. persistent or permanent atrial fibrillation;\n2. rate controlled with a resting ventricular rate of equal to or less than 110 bpm;\n3. able to perform a symptom-limited exercise test;\n4. at least 40 years of age;\n5. patient agrees to sign informed consent.\n\nExclusion Criteria:\n\n1. currently participating in routine exercise training (more than two times per week);\n2. unstable angina;\n3. uncontrolled diabetes mellitus;\n4. diagnosed severe mitral or aortic stenosis;\n5. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;\n6. unable to provide written, informed consent.'}, 'identificationModule': {'nctId': 'NCT02602457', 'briefTitle': 'Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)', 'orgStudyIdInfo': {'id': '20150427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate-intensity continuous exercise', 'description': 'Moderate-intensity continuous exercise training', 'interventionNames': ['Behavioral: moderate-intensity continuous exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'High-Intensity Interval Training', 'description': 'High-Intensity Interval Training', 'interventionNames': ['Behavioral: high-intensity interval training']}], 'interventions': [{'name': 'moderate-intensity continuous exercise training', 'type': 'BEHAVIORAL', 'description': 'Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.', 'armGroupLabels': ['Moderate-intensity continuous exercise']}, {'name': 'high-intensity interval training', 'type': 'BEHAVIORAL', 'description': 'Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.', 'armGroupLabels': ['High-Intensity Interval Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Insititue', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Jennifer L Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-04', 'type': 'RELEASE'}, {'date': '2024-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ottawa Heart Institute Research Corporation'}}}}