Impact of a Physical Exercise Program in Cardiopulmonary RehAbilitation In Patients With Chronic Chagas Heart Disease: a Randomized Controlled Trial (PEACH Trial)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chagas Disease
- Sponsor
- Evandro Chagas National Institute of Infectious Disease
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Functional capacity measured by peak exercise oxygen consumption
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Fernanda de Souza Nogueira Sardinha Mendes
Researcher
Evandro Chagas National Institute of Infectious Disease
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Functional capacity measured by peak exercise oxygen consumption
Time Frame: Changes from baselint at three and six months
This measure is taken during a maximal progressive cardiopulmonary exercise test.
Secondary Outcomes
- Muscle respiratory strength(Changes from baselint at three and six months)
- Body composition (body fat percentage)(Changes from baselint at three and six months)
- Cardiac function (maily ejection fraction)(Changes from baselint at three and six months)
- Laboratorial biomarkers composite(Changes from baselint at three and six months)
- Quality of life(Changes from baselint at three and six months)
- 24 hours Holter(Changes from baselint at three and six months)
- Nutritional assessment(Changes from baselint at three and six months)
- Pharmaceutical assessment(Changes from baselint at three and six months)
- Microvascular reactivity(Changes from baselint at three and six months)
- Body mass index(Changes from baselint at three and six months)