Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-07 @ 12:18 PM
Study NCT ID:
NCT02219451
Status:
COMPLETED
Last Update Posted:
2014-08-19
First Post:
2014-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2014-08-04', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autonomic control', 'timeFrame': '4 months', 'description': 'To asses the effects of exercise training on sympathetic modulation by analyze of autonomic control in chronic heart failure patients after 4 months protocol.Time series of muscle sympathetic nerve activity and systolic arterial pressure were analyzed by autoregressive spectral analysis'}], 'secondaryOutcomes': [{'measure': 'Arterial baroreflex control', 'timeFrame': '4 months', 'description': 'To asses the effects of exercise training on arterial baroreflex by analyze of arterial baroreflex control in chronic heart failure patients after 4 months. The arterial baroreflex control was analyzed by bivariate autoregressive.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic heart failure', 'exercise training', 'Sympathetic modulation', 'arterial baroreflex control'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '25747752', 'type': 'DERIVED', 'citation': 'Groehs RV, Toschi-Dias E, Antunes-Correa LM, Trevizan PF, Rondon MU, Oliveira P, Alves MJ, Almeida DR, Middlekauff HR, Negrao CE. Exercise training prevents the deterioration in the arterial baroreflex control of sympathetic nerve activity in chronic heart failure patients. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1096-102. doi: 10.1152/ajpheart.00723.2014. Epub 2015 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure.', 'detailedDescription': 'Retrospective study. Patients were recruited by database from Rehabilitation Unit of Cardiovascular Rehabilitation and Exercise Physiology of the Heart Institute (InCor). The aim of this study is to assess the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure. The investigators studied twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class II to III of New York Heart Association, left ventricular ejection fraction (LVEF) ≤40% and peak oxygen uptake (VO2) ≤20. The exclusion criteria were recent myocardial infarction or unstable angina (\\<3 months), heart failure duration (\\<3 months), permanent pacemaker dependence, atrial fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular exercise program. They were assigned to 2 groups: Untrained (n=13) and trained (n=13).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic heart failure\n* Age 30 to 70 years\n* Functional class II to III of New York Heart Association\n* Left ventricular ejection fraction (LVEF) ≤40%\n* Peak oxygen uptake (VO2) ≤20\n\nExclusion Criteria:\n\n* Recent myocardial infarction or unstable angina (\\<3 months)\n* heart failure duration (\\<3 months)\n* Permanent pacemaker dependence\n* Atrial fibrillation\n* Skeletal muscle abnormality (e.g., arthritis)\n* Participation in a regular exercise program'}, 'identificationModule': {'nctId': 'NCT02219451', 'briefTitle': 'Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Exercise Training Improves Oscillatory Pattern and Arterial Baroreflex Control of Sympathetic Nerve Activity in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'sympathetic modulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise training', 'description': 'We studied twenty-six chronic heart failure outpatients and they were assigned to 2 groups: Untrained (n=13) and trained (n=13).', 'interventionNames': ['Other: exercise training']}], 'interventions': [{'name': 'exercise training', 'type': 'OTHER', 'description': 'exercise training', 'armGroupLabels': ['exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Coração - HC/FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Heart Institute HC/FMUSP, HC/FMUSP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute, University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'InCor Heart Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Raphaela Vilar Ramalho Groehs', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}