Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-02 @ 5:34 PM
Study NCT ID:
NCT02106533
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2014-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Exercise on Ventilatory Efficiency in CAD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-07', 'studyFirstSubmitDate': '2014-03-27', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilatory efficiency in patients with coronary artery disease', 'timeFrame': 'up to 3 months of the interventions', 'description': 'Measurements of ventilatory efficiency during cardiopulmonary exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Exercise', 'Ventilatory efficiency'], 'conditions': ['Coronary Artery Disease', 'Exercise Addiction', 'Complication, Cardio-respiratory']}, 'referencesModule': {'references': [{'pmid': '25672429', 'type': 'DERIVED', 'citation': 'Prado DM, Rocco EA, Silva AG, Silva PF, Lazzari JM, Assumpcao GL, Thies SB, Suzaki CY, Puig RS, Furlan V. The influence of aerobic fitness status on ventilatory efficiency in patients with coronary artery disease. Clinics (Sao Paulo). 2015 Jan;70(1):46-51. doi: 10.6061/clinics/2015(01)09.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to test the hypothesis that patients with coronary artery disease with lower aerobic fitness exhibit greater responsiveness on improving ventilatory efficiency after aerobic exercise training.', 'detailedDescription': 'Measurements of ventilatory efficiency during cardiorespiratory exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs. In addition, a growing body of studies has demonstrated that lower ventilatory efficiency during exercise is considered an important predictor of risk mortality, hospitalization, and other outcomes than peak VO2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '48 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* was stable coronary artery disease diagnosed by coronary angiography\n\nExclusion Criteria:\n\n* unstable angina pectoris,\n* complex ventricular arrhythmias,\n* pulmonary congestion and\n* orthopaedic or neurological limitations to exercise'}, 'identificationModule': {'nctId': 'NCT02106533', 'briefTitle': 'Aerobic Exercise on Ventilatory Efficiency in CAD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital TotalCor'}, 'officialTitle': 'Effect of Aerobic Exercise Training on Ventilatory Efficiency in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': '53/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 peak VO2 <17.5 ml/kg/min', 'description': 'The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP.', 'interventionNames': ['Other: Aerobic exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 peak VO2 > 17.5 < 24.5 ml/kg/min', 'description': 'The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.', 'interventionNames': ['Other: Aerobic exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 peak VO2 > 24.5 ml/kg/min', 'description': 'The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill . Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.', 'interventionNames': ['Other: Aerobic exercise training']}], 'interventions': [{'name': 'Aerobic exercise training', 'type': 'OTHER', 'description': 'The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.', 'armGroupLabels': ['Group 1 peak VO2 <17.5 ml/kg/min', 'Group 2 peak VO2 > 17.5 < 24.5 ml/kg/min', 'Group 3 peak VO2 > 24.5 ml/kg/min']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Danilo ML Prado, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital TotalCor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital TotalCor', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Danilo Marcelo Leite do Prado', 'investigatorAffiliation': 'Hospital TotalCor'}}}}