Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT00966303
Status:
COMPLETED
Last Update Posted:
2009-10-06
First Post:
2009-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Rehabilitation in Cardiomyopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-05', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of a cardiac rehabilitation in patients with cardiomyopathy, evaluating the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life.', 'timeFrame': '8 weeks / Twice a week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rehabilitation', 'dyspnea', 'strength'], 'conditions': ['Cardiomyopathies']}, 'descriptionModule': {'briefSummary': 'This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life in patients after cardiac rehabilitation associated with the diaphragmatic muscle training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Cardiomyopathies in functional class III or IV (New York Heart Association)\n* Aged over 18 years\n* Body mass index below 30 kg/m2\n\nExclusion Criteria:\n\n* Confused and depressed patients\n* Cardiac instability and worsening dyspnea after initiation of treatment'}, 'identificationModule': {'nctId': 'NCT00966303', 'briefTitle': 'Cardiac Rehabilitation in Cardiomyopathies', 'organization': {'class': 'OTHER', 'fullName': 'Fortaleza University'}, 'officialTitle': 'The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy', 'orgStudyIdInfo': {'id': 'FR150091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac Rehabilitation', 'description': '9 patients with cardiomyopathy in functional class III or IV, submitted to an 8-week program with exercises and respiratory muscle training.', 'interventionNames': ['Other: Cardiac Rehabilitation with diaphragmatic muscle training']}], 'interventions': [{'name': 'Cardiac Rehabilitation with diaphragmatic muscle training', 'type': 'OTHER', 'description': 'Stretching and aerobic exercises and respiratory muscle training with a Threshold ® device, with load of 40% of the maximal inspiratory pressure (MIP), two times a week during one hour.', 'armGroupLabels': ['Cardiac Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Fortaleza University - Nucleus of Integrated Medical Attention', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}], 'overallOfficials': [{'name': 'Davi S Sales, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fortaleza University'}, {'name': "Daniela GB Mont'Alverne, Doctor", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fortaleza University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fortaleza University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edson Queiroz Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Davi Simões Sales', 'oldOrganization': 'Fortaleza University'}}}}