NCT02517632

Physical Exercise Program in Chronic Chagas Heart Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Evandro Chagas National Institute of Infectious Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chagas Disease
• Chagas Cardiomyopathy

Interventions

Type	Name	Description
BEHAVIORAL	Exercise, 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.
BEHAVIORAL	Nutritional 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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-08-07
• Last updated: 2017-07-27

Locations

1 site across 1 country: Brazil