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Physical Exercise Program in Chronic Chagas Heart Disease (PEACH)

Primary Purpose

Chagas Disease, Chagas Cardiomyopathy

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Exercise, nutritional and pharmaceutical counceling
Nutritional and pharmaceutical counceling
Sponsored by
Evandro Chagas National Institute of Infectious Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease focused on measuring Physical activity, Cardiac rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise group

Control group

Arm Description

This arm will be submitted to a exercise session and counseling from pharmaceutical and nutritional professionals.

This arm will have only the counseling from pharmaceutical and nutritional professionals.

Outcomes

Primary Outcome Measures

Functional capacity measured by peak exercise oxygen consumption
This measure is taken during a maximal progressive cardiopulmonary exercise test.

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2015
Last Updated
July 25, 2017
Sponsor
Evandro Chagas National Institute of Infectious Disease
Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02517632
Brief Title
Physical Exercise Program in Chronic Chagas Heart Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evandro Chagas National Institute of Infectious Disease
Collaborators
National Institute of Cardiology, Laranjeiras, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease, Chagas Cardiomyopathy
Keywords
Physical activity, Cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
This arm will be submitted to a exercise session and counseling from pharmaceutical and nutritional professionals.
Arm Title
Control group
Arm Type
Other
Arm Description
This arm will have only the counseling from pharmaceutical and nutritional professionals.
Intervention Type
Behavioral
Intervention Name(s)
Exercise, nutritional and pharmaceutical counceling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional and pharmaceutical counceling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity measured by peak exercise oxygen consumption
Description
This measure is taken during a maximal progressive cardiopulmonary exercise test.
Time Frame
Changes from baselint at three and six months
Secondary Outcome Measure Information:
Title
Muscle respiratory strength
Description
Maximal inspiratory pressure and maximal expiratory pressure (cmH2O)
Time Frame
Changes from baselint at three and six months
Title
Body composition (body fat percentage)
Description
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.
Time Frame
Changes from baselint at three and six months
Title
Cardiac function (maily ejection fraction)
Description
Meaured by echocardiography
Time Frame
Changes from baselint at three and six months
Title
Laboratorial biomarkers composite
Description
Total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol,triacylglycerol, glucose, glycated hemoglobin, inflammatory cytokines, Brain Natriuretic Peptide and components of oxidative stress.
Time Frame
Changes from baselint at three and six months
Title
Quality of life
Description
Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105.
Time Frame
Changes from baselint at three and six months
Title
24 hours Holter
Description
Cardiac rhythm through continuous dynamic ECG
Time Frame
Changes from baselint at three and six months
Title
Nutritional assessment
Description
By semiquantitative food frequency questionnaire and 24-hour food intake recall.
Time Frame
Changes from baselint at three and six months
Title
Pharmaceutical assessment
Description
Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm.
Time Frame
Changes from baselint at three and six months
Title
Microvascular reactivity
Description
Measured by laser speckle flowmetry
Time Frame
Changes from baselint at three and six months
Title
Body mass index
Description
Measured by the body weight (kg) divided by squared height (in meters).
Time Frame
Changes from baselint at three and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Mendes, M.D.
Organizational Affiliation
Evandro Chagas National Institute of Infectious Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27590681
Citation
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.
Results Reference
derived

Learn more about this trial

Physical Exercise Program in Chronic Chagas Heart Disease

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