Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-17 @ 12:50 AM
Study NCT ID:
NCT02765568
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2016-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}, {'id': 'D000088783', 'term': 'Nordic Walking'}], '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'}, {'id': 'D016138', 'term': 'Walking'}, {'id': 'D008124', 'term': 'Locomotion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Capacity', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test'}], 'secondaryOutcomes': [{'measure': 'Functional Fitness', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in functional fitness from baseline to 12 weeks and baseline to 26 weeks are measured by the Senior Fitness Test'}, {'measure': 'Aortic stiffness', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in aortic stiffness from baseline to 12 weeks and baseline to 26 weeks are measured by pulse wave velocity'}, {'measure': 'Body Composition', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by the waist circumference.'}, {'measure': 'Body Composition', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance.'}, {'measure': 'Body Composition', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by body mass index.'}, {'measure': 'Depression', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in depression from baseline to 12 weeks and baseline to 26 weeks are measured by the Beck Depression Inventory-II questionnaire'}, {'measure': 'Quality of Life - SF36', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the Short Form-36.'}, {'measure': 'Quality of Life - HeartQoL', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the HeartQoL questionnaire'}, {'measure': 'Exercise Adherence', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in exercise adherence from baseline to 12 weeks and baseline to 26 weeks are measured by the Actigraph accelerometer'}, {'measure': 'Depression mechanisms', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma brain derived neurotrophic factor.'}, {'measure': 'Depression mechanisms', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma irisin.'}, {'measure': 'Depression mechanisms', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma kynurenine.'}, {'measure': 'Lipid and glucose profile', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma total cholesterol.'}, {'measure': 'Lipid and glucose profile', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Low Density Lipoprotein'}, {'measure': 'Lipid and glucose profile', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma High Density Lipoprotein.'}, {'measure': 'Lipid and glucose profile', 'timeFrame': 'Baseline to 12 weeks and Baseline to 26 weeks', 'description': 'Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Hemoglobin A1c'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention (PCI)'], 'conditions': ['Coronary Artery Disease (CAD)']}, 'referencesModule': {'references': [{'pmid': '37184470', 'type': 'DERIVED', 'citation': 'Marcal IR, Cotie LM, Ribeiro I, Reed JL. The Effects of Different Exercise Modalities and Intensities on Arterial Stiffness in Patients With Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 Sep 1;43(5):384-385. doi: 10.1097/HCR.0000000000000799. Epub 2023 May 15. No abstract available.'}, {'pmid': '36905198', 'type': 'DERIVED', 'citation': 'Garneau L, Terada T, Mistura M, Mulvihill EE, Reed JL, Aguer C. Exercise training reduces circulating cytokines in male patients with coronary artery disease and type 2 diabetes: A pilot study. Physiol Rep. 2023 Mar;11(5):e15634. doi: 10.14814/phy2.15634.'}]}, 'descriptionModule': {'briefSummary': 'Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. Nordic walking (NW) and high-intensity interval training (HIIT) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional MICE. The main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including NW and HIIT on exercise capacity, quality of life and depression after a 12-week program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks);\n* Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program;\n* Patient is able to walk independently\n* Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;\n* At least 40 years of age;\n* Patient is willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Currently participating in routine exercise training (\\>2x/week) and/or using Nordic Walking poles;\n* Active infection or inflammatory condition;\n* Over 75 years of age;\n* Persistent or permanent atrial fibrillation;\n* Pregnant, lactating or planning to become pregnant during the trial period;\n* Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;\n* Unable to read and understand English or French;\n* Unwilling or unable to return for follow-up visit at weeks 12 and 26;'}, 'identificationModule': {'nctId': 'NCT02765568', 'acronym': 'CRX-Modalities', 'briefTitle': 'Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes', 'orgStudyIdInfo': {'id': '20160127-01H'}}, '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': 'Nordic Walking', 'description': 'Nordic Walking', 'interventionNames': ['Behavioral: Nordic Walking']}, {'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training', 'description': 'High Intensity Interval Training', 'interventionNames': ['Behavioral: High Intensity Interval Training']}], 'interventions': [{'name': 'High Intensity Interval Training', 'type': 'BEHAVIORAL', 'otherNames': ['HIIT'], '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']}, {'name': 'Moderate Intensity Continuous Exercise Training', 'type': 'BEHAVIORAL', 'otherNames': ['MICE'], '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': 'Nordic Walking', 'type': 'BEHAVIORAL', 'otherNames': ['NW'], 'description': 'Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks', 'armGroupLabels': ['Nordic Walking']}]}, '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}, {'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}