Clinical Trial: Physical Exercise Program in Chronic Chagas Heart Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Evandro Chagas National Institute of Infectious Disease

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Muscle respiratory strength [ Time Frame: Changes from baselint at three and six months ]
    Maximal inspiratory pressure and maximal expiratory pressure (cmH2O)
  • 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.
  • Cardiac function (maily ejection fraction) [ Time Frame: Changes from baselint at three and six months ]
    Meaured by echocardiography
  • 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.
  • 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.
  • 24 hours Holter [ Time Frame: Changes from baselint at three and six months ]
    Cardiac rhythm through continuous dynamic ECG
  • Nutritional assessment [ Time Frame: Changes from baselint at three and six months ]
    By semiquantitative food frequency questionnaire and 24-hour food intake recall.
  • Pharmaceutical assessment [ Time Frame: Changes from baselint at three and six months ]
    Semi-structured questionnaires, Morisky´s test, Naranjo Algorithm.
  • Microvascular reactivity [ Time Frame: Changes from baselint at three and six months ]
    Measured by laser speckle flowmetry
  • 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).


Original Secondary Outcome: Same as current

Information By: Evandro Chagas National Institute of Infectious Disease

Dates:
Date Received: August 5, 2015
Date Started: March 2015
Date Completion: January 2017
Last Updated: August 2, 2016
Last Verified: August 2016