Cardiac Rehabilitation in Chagas Heart Failure

Phase 2

Completed

• Conditions: Chagas Cardiomyopathy; Chagas Disease
• Interventions: Behavioral: Exercise, nutritional and pharmaceutical counseling

• Registration Number: NCT02516293
• Lead Sponsor: Evandro Chagas National Institute of Infectious Disease

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Study First Submitted: 2015-07-31
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Study First Posted: 2015-08-05
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Exercise, nutritional and pharmaceutical counseling	* Physical exercise intervention * Nutritional counseling * Pharmaceutical counseling

Primary Outcome Measures

Name	Time	Method
Functional Capacity (VO2 max)	Change from baseline at 4 and 8 months	VO2 max (ml/kg/min)

Secondary Outcome Measures

Name	Time	Method
Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)	Change from baseline at 4 and 8 months	Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)
Body composition (body fat percentage)	Change from baseline at 4 and 8 months	Body fat percentage (%)
Cardiac function (mainly ejection fraction)	Change from baseline at 8 months	Ejection fraction (%)
Biomarkers (lipid profile and glucose)	Change from baseline at 8 months	Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)
Biomarkers (glycated hemoglobin)	Change from baseline at 8 months	Glycated hemoglobin (%)
Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)	Change from baseline at 8 months	MLHFQ Score ranging from 0 to 105
Anthropometry	Change from baseline at 4 and 8 months	Waist and hip circumference (cm)

Trial Locations

Locations (1)

Evandro Chagas National Institute of Infectious Disease; 🇧🇷 Rio de Janeiro, RJ, Brazil