Physical Exercise Program in Chronic Chagas Heart Disease

Study Overview
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Brief Summary
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The aim of this investigation is to evaluate the impact of exercise in a cardiac rehabilitation program on functional capacity, clinical markers, quality of life and biomarkers in patients with chronic chagasic cardiomyopathy.

Detailed Description
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The present study consisted in a randomized clinical 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 are randomly divided in two groups: intervention and control groups. Safety analysis will be performed by monitoring any symptoms presented during data collection and follow-up study. One of the potential risks that the patient may experience during the study is a noninvasive test that will be performed on a treadmill in a controlled environment, with the possibility of the appearance of symptoms such as fatigue, dyspnea, chest pain, dizziness, with minimal chances of occurring complications of difficult clinical control. Except for the blood test and the cardiopulmonary exercise test, the other tests to be performed are non-invasive and do not bring any risk to the participant's health. Will be collect 10 ml of blood which will be stored for up to five years for biomarker assessments. During the exercise sessions, patients will be clinically monitored for decompensation, need for hospitalization and suspend or end the participation on the study. All cases will be individually assessed to determine the reversibility of the clinical status. Those cases will continue to be followed by the assistant staff, offering all the clinical support available in INI.

Official Title
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Impact of a Physical Exercise Program in Cardiopulmonary RehAbilitation In Patients With Chronic Chagas Heart Disease: a Randomized Controlled Trial (PEACH Trial)

Conditions
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Chagas Disease, Chagas Cardiomyopathy

Intervention / Treatment
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* Behavioral: Exercise, nutritional and pharmaceutical counceling
* Behavioral: Nutritional and pharmaceutical counceling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Chagas disease diagnosis by serology; (2) chronic chagasic cardiomyopathy, with left ventricular ejection fraction <45% or compensated heart failure (3) clinical stability in the last three months, (4) adherence to the ambulatory clinical treatment and (5) age above 18 years. Exclusion Criteria: (1) pregnancy, (2) neuromuscular limitations, (3) tobacco use, (4) evidence of nonchagasic heart disease, (5) systemic conditions that limits exercise practice or hemodynamic stress tests (6) unavailability to attend three times a week for a minimum of six months, (7) practitioners of regular exercise and (8) claustrophobia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>This arm will be submitted to a exercise session and counseling from pharmaceutical and nutritional professionals. | Behavioral: Exercise, nutritional and pharmaceutical counceling<br>* The exercise group will be submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during 6-month period, and a monthly counseling from pharmaceutical and nutritional professionals provided during the follow-up and consisted on general guidance about healthy eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.<br>|
| Other: Control group<br>This arm will have only the counseling from pharmaceutical and nutritional professionals. | Behavioral: Nutritional and pharmaceutical counceling<br>* The control group will be submitted to a monthly counseling from pharmaceutical and nutritional professionals provided during the follow-up and consisted on general guidance about healthy eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity measured by peak exercise oxygen consumption | This measure is taken during a maximal progressive cardiopulmonary exercise test. | Changes from baselint at three and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle respiratory strength | Maximal inspiratory pressure and maximal expiratory pressure (cmH2O) | Changes from baselint at three and six months | 
| Body composition (body fat percentage) | Measurement of skinfold thickness were taken at the chest, midaxillary, triceps, subscapular, abdomen, suprailiac and thigh sites on the right side of the body while standing in a relaxed position. The sum of these seven skinfold thicknesses was used to estimate body composition by Jackson & Pollock equation. | Changes from baselint at three and six months | 
| Cardiac function (maily ejection fraction) | Meaured by echocardiography | Changes from baselint at three and six months | 
| Laboratorial biomarkers composite | Total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol,triacylglycerol, glucose, glycated hemoglobin, inflammatory cytokines, Brain Natriuretic Peptide and components of oxidative stress. | Changes from baselint at three and six months | 
| Quality of life | Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105. | Changes from baselint at three and six months | 
| 24 hours Holter | Cardiac rhythm through continuous dynamic ECG | Changes from baselint at three and six months | 
| Nutritional assessment | By semiquantitative food frequency questionnaire and 24-hour food intake recall. | Changes from baselint at three and six months | 
| Pharmaceutical assessment | Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm. | Changes from baselint at three and six months | 
| Microvascular reactivity | Measured by laser speckle flowmetry | Changes from baselint at three and six months | 
| Body mass index | Measured by the body weight (kg) divided by squared height (in meters). | Changes from baselint at three and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Cardiac rehabilitation