Physical Exercise Program in Chronic Chagas Heart Disease (PEACH)

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

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.

Study Overview

• Status: Completed
• Conditions: Chagas Cardiomyopathy; Chagas Disease
• Intervention / Treatment: Behavioral: Exercise, nutritional and pharmaceutical counceling; Behavioral: Nutritional and pharmaceutical counceling

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040-360
    • Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; This arm will be submitted to a exercise session and counseling from pharmaceutical and nutritional professionals.	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.
Other: Control group; This arm will have only the counseling from pharmaceutical and nutritional professionals.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Evandro Chagas National Institute of Infectious Disease
• Collaborators: National Institute of Cardiology, Laranjeiras, Brazil
• Investigators: Principal Investigator: Fernanda Mendes, M.D., Evandro Chagas National Institute of Infectious Disease

Publications and helpful links

General Publications

• Mendes Fde S, Sousa AS, Souza FC, Pinto VL, Silva PS, Saraiva RM, Xavier SS, Veloso HH, Holanda MT, Costa AR, Carneiro FM, Silva GM, Borges JP, Tibirica E, Pinheiro RO, Lara FA, Hasslocher-Moreno AM, Brasil PE, Mediano MF. Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study). Trials. 2016 Sep 2;17(1):433. doi: 10.1186/s13063-016-1553-4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Physical activity; Cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Heart Diseases; Cardiomyopathies; Chagas Cardiomyopathy; Chagas Disease
• Other Study ID Numbers: CAAE:38038914.6.0000.5262