Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-01-16 @ 8:06 PM
Study NCT ID:
NCT02168712
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2014-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2014-06-18', 'lastUpdatePostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': '2 months', 'description': 'The incidence of cardiovascular adverse events in each group will be compared'}], 'primaryOutcomes': [{'measure': 'Impact on functional capacity', 'timeFrame': '2 months', 'description': 'Basal and peak oxygen consumption values will be measured.'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '2 months', 'description': 'Quality of life will be compared between the two arms with one generic questionnaire (SF-36) and one ischemic heart disease specific questionnaire (MacNew)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Heart Disease', 'Interval exercise training', 'Continuous exercise training', 'Quality of life', 'Safety'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. However, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality.\n\nThe purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application.\n\nWe included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary heart Disease, with functional class II-III according to New York Heart Association classification system.\n* At least 4 weeks from acute cardiac event, percutaneous or surgery revascularization.\n* Optimized medical treatment in adequate doses ( betablockers, ACE inhibitors, ARA II, statins and antiplatelet drugs)\n* Age \\> 18 years old.\n* Willing to participate and sign an informed consent form\n\nExclusion Criteria:\n\n* Residual ischemia waiting for revascularization.\n* Any cardiac event for the last 4 weeks\n* Abnormal Ergometry with hemodynamic or clinically significant arrhythmias during the procedure.\n* History of severe ventricular arrhythmia\n* Uncontrolled glycaemia or blood pressure\n* Moderate to severe Chronic Pulmonary Obstructive Disease\n* Osteomuscular and/or mental disorder that hampers an adequate adherence to the intervention program\n* Other vascular diseases: rheumatologic/ autoimmune disorders, thrombopathies, hemophilia.\n* Active oncologic disease.\n* Treatment with corticosteroids.'}, 'identificationModule': {'nctId': 'NCT02168712', 'briefTitle': 'Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'EO31/2013-HIE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate continuous exercise training', 'description': 'Moderate intensity continuous exercise training', 'interventionNames': ['Other: Moderate continuous exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Interval exercise training', 'description': 'High intensity interval exercise training', 'interventionNames': ['Other: Interval exercise training']}], 'interventions': [{'name': 'Moderate continuous exercise training', 'type': 'OTHER', 'armGroupLabels': ['Moderate continuous exercise training']}, {'name': 'Interval exercise training', 'type': 'OTHER', 'armGroupLabels': ['Interval exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28342', 'city': 'Valdemoro', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Elena', 'geoPoint': {'lat': 40.19081, 'lon': -3.67887}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Rehabilitation Department', 'investigatorFullName': 'KOLDO VILLELABEITIA JAUREGUIZAR', 'investigatorAffiliation': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}}}}