Cardiac Rehabilitation in Chagas Heart Failure

NCT ID: NCT02516293

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Chagas Disease; Chagas Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

• Physical exercise intervention
• Nutritional counseling
• Pharmaceutical counseling

Group Type: EXPERIMENTAL

Exercise, nutritional and pharmaceutical counseling

Intervention Type: BEHAVIORAL

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.

Interventions

Exercise, nutritional and pharmaceutical counseling

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients at the stages C or D of Chagas cardiomyopathy
• Patients receiving standard optimized medical therapy
• Patients with good adherence to outpatient treatment within the last three months.

Exclusion Criteria

• Those who were not able to attend three weekly training sessions,
• 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)
• Practitioners of regular exercise.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evandro Chagas National Institute of Infectious Disease

OTHER

Sponsor Role: lead

Responsible Party

Mauro Felippe Felix Mediano

Clinical Researcher in Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea S Sousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Evandro Chagas National Institute of Infectious Disease

Locations

Evandro Chagas National Institute of Infectious Disease

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

CAAE 0055.0.009.000-11

Identifier Type: -

Identifier Source: org_study_id