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Physical Exercise Program in Chronic Chagas Heart Disease (PEACH)

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ClinicalTrials.gov Identifier: NCT02517632
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : July 27, 2017
Sponsor:
Collaborator:
National Institute of Cardiology, Laranjeiras, Brazil
Information provided by (Responsible Party):
Fernanda de Souza Nogueira Sardinha Mendes, Evandro Chagas National Institute of Infectious Disease

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.

Condition or disease Intervention/treatment Phase
Chagas Disease Chagas Cardiomyopathy Behavioral: Exercise, nutritional and pharmaceutical counceling Behavioral: Nutritional and pharmaceutical counceling Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Physical Exercise Program in Cardiopulmonary RehAbilitation In Patients With Chronic Chagas Heart Disease: a Randomized Controlled Trial (PEACH Trial)
Actual Study Start Date : March 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Muscle respiratory strength [ Time Frame: Changes from baselint at three and six months ]
    Maximal inspiratory pressure and maximal expiratory pressure (cmH2O)

  2. Body composition (body fat percentage) [ Time Frame: Changes from baselint at three and six months ]
    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.

  3. Cardiac function (maily ejection fraction) [ Time Frame: Changes from baselint at three and six months ]
    Meaured by echocardiography

  4. Laboratorial biomarkers composite [ Time Frame: Changes from baselint at three and six months ]
    Total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol,triacylglycerol, glucose, glycated hemoglobin, inflammatory cytokines, Brain Natriuretic Peptide and components of oxidative stress.

  5. Quality of life [ Time Frame: Changes from baselint at three and six months ]
    Minnesota Living with Heart Failure questionnaire (MLHFQ). Score ranging from 0 - 105.

  6. 24 hours Holter [ Time Frame: Changes from baselint at three and six months ]
    Cardiac rhythm through continuous dynamic ECG

  7. Nutritional assessment [ Time Frame: Changes from baselint at three and six months ]
    By semiquantitative food frequency questionnaire and 24-hour food intake recall.

  8. Pharmaceutical assessment [ Time Frame: Changes from baselint at three and six months ]
    Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm.

  9. Microvascular reactivity [ Time Frame: Changes from baselint at three and six months ]
    Measured by laser speckle flowmetry

  10. Body mass index [ Time Frame: Changes from baselint at three and six months ]
    Measured by the body weight (kg) divided by squared height (in meters).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517632


Locations
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Brazil
Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.
Rio de Janeiro, Brazil, 21040-360
Sponsors and Collaborators
Evandro Chagas National Institute of Infectious Disease
National Institute of Cardiology, Laranjeiras, Brazil
Investigators
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Principal Investigator: Fernanda Mendes, M.D. Evandro Chagas National Institute of Infectious Disease

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernanda de Souza Nogueira Sardinha Mendes, Researcher, Evandro Chagas National Institute of Infectious Disease
ClinicalTrials.gov Identifier: NCT02517632     History of Changes
Other Study ID Numbers: CAAE:38038914.6.0000.5262
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

Keywords provided by Fernanda de Souza Nogueira Sardinha Mendes, Evandro Chagas National Institute of Infectious Disease:
Physical activity
Cardiac rehabilitation

Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Chagas Disease
Chagas Cardiomyopathy
Cardiovascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases