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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
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.
Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.
Rio de Janeiro, Brazil
Functional capacity measured by peak exercise oxygen consumption
This measure is taken during a maximal progressive cardiopulmonary exercise test.
Time frame: Changes from baselint at three and six months
Muscle respiratory strength
Maximal inspiratory pressure and maximal expiratory pressure (cmH2O)
Time frame: 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.
Time frame: Changes from baselint at three and six months
Cardiac function (maily ejection fraction)
Meaured by echocardiography
Time frame: 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.
Time frame: Changes from baselint at three and six months
Quality of life
Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105.
Time frame: Changes from baselint at three and six months
24 hours Holter
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Cardiac rhythm through continuous dynamic ECG
Time frame: Changes from baselint at three and six months
Nutritional assessment
By semiquantitative food frequency questionnaire and 24-hour food intake recall.
Time frame: Changes from baselint at three and six months
Pharmaceutical assessment
Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm.
Time frame: Changes from baselint at three and six months
Microvascular reactivity
Measured by laser speckle flowmetry
Time frame: Changes from baselint at three and six months
Body mass index
Measured by the body weight (kg) divided by squared height (in meters).
Time frame: Changes from baselint at three and six months