Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT01747395
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2012-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training Associated With Inspiratory Muscle Training in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2012-12-06', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autonomic control', 'timeFrame': '4 months', 'description': 'Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.'}], 'secondaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '4 months', 'description': 'Exercise training associated with inspiratory muscle training will improve peak oxygen consumption'}, {'measure': 'Quality of life', 'timeFrame': '4 months', 'description': 'Exercise training associated with inspiratory muscle training will improve quality of life'}, {'measure': 'Blood inflammatory markers', 'timeFrame': '4 months', 'description': 'Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers'}, {'measure': 'Muscular evaluation', 'timeFrame': '4 months', 'description': 'Exercise training associated with inspiratory muscle training will increase skeletal muscle strength'}, {'measure': 'Respiratoy muscle function', 'timeFrame': '4 months', 'description': 'Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Exercise and Physical Fitness'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '31743617', 'type': 'DERIVED', 'citation': 'Antunes-Correa LM, Trevizan PF, Bacurau AVN, Ferreira-Santos L, Gomes JLP, Urias U, Oliveira PA, Alves MJNN, de Almeida DR, Brum PC, Oliveira EM, Hajjar L, Kalil Filho R, Negrao CE. Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):89-102. doi: 10.1002/jcsm.12495. Epub 2019 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.', 'detailedDescription': 'The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with systolic heart failure and New York Heart Association (NYHA) class II-III\n* Left ventricular ejection fraction less than 40%\n* Peak Oxygen Consumption less than 20 ml/Kg/min\n\nExclusion Criteria:\n\n* Chronic Obstructive Pulmonary Disease\n* Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases\n* Recent myocardial infarction or cardiac surgery (less than 6 months)\n* Unstable angina pectoris\n* Atrial Fibrillation\n* Pacemakers users\n* Actual Smoker\n* Pregnant\n* Changing medication or hospital admission'}, 'identificationModule': {'nctId': 'NCT01747395', 'briefTitle': 'Exercise Training Associated With Inspiratory Muscle Training in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'ICRESP814/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No exercise group (sedentary)'}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise Training', 'description': 'Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths', 'interventionNames': ['Other: Exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Inspiratory Muscle Training', 'description': 'Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths', 'interventionNames': ['Other: Exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic+Inspiratory Muscle Training', 'description': 'Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths', 'interventionNames': ['Other: Exercise training']}], 'interventions': [{'name': 'Exercise training', 'type': 'OTHER', 'description': 'The heart failure patients are subjected to differents protocols of physical training', 'armGroupLabels': ['Aerobic Exercise Training', 'Aerobic+Inspiratory Muscle Training', 'Inspiratory Muscle Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Coração - HC/FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Carlos Eduardo Negrão', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InCor, HCFMUSP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Patricia Fernandes Trevizan', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}