Physical Exercise Program in Chronic Chagas Heart Disease

Chagas Disease Clinical Trial

— PEACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517632
• Other study ID #: CAAE:38038914.6.0000.5262
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2015
• Last updated: July 25, 2017
• Start date: March 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2017
• Source: Evandro Chagas National Institute of Infectious Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy
• Chagas Disease
• Heart Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Evandro Chagas National Institute of Infectious Disease	National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle respiratory strength	Maximal inspiratory pressure and maximal expiratory pressure (cmH2O)	Changes from baselint at three and six months
Secondary	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
Secondary	Cardiac function (maily ejection fraction)	Meaured by echocardiography	Changes from baselint at three and six months
Secondary	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
Secondary	Quality of life	Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105.	Changes from baselint at three and six months
Secondary	24 hours Holter	Cardiac rhythm through continuous dynamic ECG	Changes from baselint at three and six months
Secondary	Nutritional assessment	By semiquantitative food frequency questionnaire and 24-hour food intake recall.	Changes from baselint at three and six months
Secondary	Pharmaceutical assessment	Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm.	Changes from baselint at three and six months
Secondary	Microvascular reactivity	Measured by laser speckle flowmetry	Changes from baselint at three and six months
Secondary	Body mass index	Measured by the body weight (kg) divided by squared height (in meters).	Changes from baselint at three and six months