Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-25 @ 6:07 AM
Study NCT ID:
NCT02516293
Status:
COMPLETED
Last Update Posted:
2015-08-05
First Post:
2015-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Rehabilitation in Chagas Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014355', 'term': 'Chagas Disease'}, {'id': 'D002598', 'term': 'Chagas Cardiomyopathy'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Capacity (VO2 max)', 'timeFrame': 'Change from baseline at 4 and 8 months', 'description': 'VO2 max (ml/kg/min)'}], 'secondaryOutcomes': [{'measure': 'Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)', 'timeFrame': 'Change from baseline at 4 and 8 months', 'description': 'Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)'}, {'measure': 'Body composition (body fat percentage)', 'timeFrame': 'Change from baseline at 4 and 8 months', 'description': 'Body fat percentage (%)'}, {'measure': 'Cardiac function (mainly ejection fraction)', 'timeFrame': 'Change from baseline at 8 months', 'description': 'Ejection fraction (%)'}, {'measure': 'Biomarkers (lipid profile and glucose)', 'timeFrame': 'Change from baseline at 8 months', 'description': 'Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)'}, {'measure': 'Biomarkers (glycated hemoglobin)', 'timeFrame': 'Change from baseline at 8 months', 'description': 'Glycated hemoglobin (%)'}, {'measure': 'Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)', 'timeFrame': 'Change from baseline at 8 months', 'description': 'MLHFQ Score ranging from 0 to 105'}, {'measure': 'Anthropometry', 'timeFrame': 'Change from baseline at 4 and 8 months', 'description': 'Body weight (kg)'}, {'measure': 'Anthropometry', 'timeFrame': 'Change from baseline at 4 and 8 months', 'description': 'Waist and hip circumference (cm)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chagas Disease', 'Chagas Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.', 'detailedDescription': 'The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at the stages C or D of Chagas cardiomyopathy\n* Patients receiving standard optimized medical therapy\n* Patients with good adherence to outpatient treatment within the last three months.\n\nExclusion Criteria:\n\n* Those who were not able to attend three weekly training sessions,\n* Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)\n* Practitioners of regular exercise.'}, 'identificationModule': {'nctId': 'NCT02516293', 'briefTitle': 'Cardiac Rehabilitation in Chagas Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Evandro Chagas National Institute of Infectious Disease'}, 'officialTitle': 'Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study', 'orgStudyIdInfo': {'id': 'CAAE 0055.0.009.000-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '* Physical exercise intervention\n* Nutritional counseling\n* Pharmaceutical counseling', 'interventionNames': ['Behavioral: Exercise, nutritional and pharmaceutical counseling']}], 'interventions': [{'name': 'Exercise, nutritional and pharmaceutical counseling', 'type': 'BEHAVIORAL', 'description': 'Physical exercise intervention protocol was performed three times per week, 60 minutes per session, during 8 months. Exercise sessions consisted of 30 minutes of aerobic exercise on a treadmill or on a cycle ergometer, 20 minutes of strength exercises for the major muscle groups (sit-ups, push-ups, and pull-ups), and 10 minutes of stretching exercises. Nutritional and pharmaceutical consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21040-360', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Evandro Chagas National Institute of Infectious Disease', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Andrea S Sousa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Evandro Chagas National Institute of Infectious Disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evandro Chagas National Institute of Infectious Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Researcher in Public Health', 'investigatorFullName': 'Mauro Felippe Felix Mediano', 'investigatorAffiliation': 'Evandro Chagas National Institute of Infectious Disease'}}}}