Chagas Cardiomyopathy, Chagas Disease
Conditions
Keywords
Physical activity, Cardiac rehabilitation
Brief summary
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
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.
Interventions
BEHAVIORALExercise, nutritional and pharmaceutical counceling
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.
BEHAVIORALNutritional and pharmaceutical counceling
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.
Sponsors
National Institute of Cardiology, Laranjeiras, Brazil
Evandro Chagas National Institute of Infectious Disease
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity measured by peak exercise oxygen consumption | Changes from baselint at three and six months | This measure is taken during a maximal progressive cardiopulmonary exercise test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition (body fat percentage) | Changes from baselint at three and six months | 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. |
| Cardiac function (maily ejection fraction) | Changes from baselint at three and six months | Meaured by echocardiography |
| Laboratorial biomarkers composite | Changes from baselint at three and six months | Total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol,triacylglycerol, glucose, glycated hemoglobin, inflammatory cytokines, Brain Natriuretic Peptide and components of oxidative stress. |
| Quality of life | Changes from baselint at three and six months | Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105. |
| Muscle respiratory strength | Changes from baselint at three and six months | Maximal inspiratory pressure and maximal expiratory pressure (cmH2O) |
| Nutritional assessment | Changes from baselint at three and six months | By semiquantitative food frequency questionnaire and 24-hour food intake recall. |
| Pharmaceutical assessment | Changes from baselint at three and six months | Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm. |
| Microvascular reactivity | Changes from baselint at three and six months | Measured by laser speckle flowmetry |
| Body mass index | Changes from baselint at three and six months | Measured by the body weight (kg) divided by squared height (in meters). |
| 24 hours Holter | Changes from baselint at three and six months | Cardiac rhythm through continuous dynamic ECG |
Countries
Brazil
Outcome results
None listed