Clinical trial NCT02517632: Physical Exercise Program in Chronic Chagas Heart Disease
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chagas Disease
Chagas Cardiomyopathy
Keywords: Physical activity
Cardiac rehabilitation
Lead sponsor: Evandro Chagas National Institute of Infectious Disease
Sponsor class: OTHER
Collaborators: name: National Institute of Cardiology, Laranjeiras, Brazil
First posted: 2015-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group performed exercise sessions, pharmaceutical and nutritional counceling. The control group had only pharmaceutical and nutritional counceling.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional capacity measured by peak exercise oxygen consumption
timeFrame: Changes from baselint at three and six months
Secondary outcomes:
measure: Muscle respiratory strength
timeFrame: Changes from baselint at three and six months
measure: Body composition (body fat percentage)
timeFrame: Changes from baselint at three and six months
measure: Cardiac function (maily ejection fraction)
timeFrame: Changes from baselint at three and six months
measure: Laboratorial biomarkers composite
timeFrame: Changes from baselint at three and six months
measure: Quality of life
timeFrame: Changes from baselint at three and six months
measure: 24 hours Holter
timeFrame: Changes from baselint at three and six months
measure: Nutritional assessment
timeFrame: Changes from baselint at three and six months
measure: Pharmaceutical assessment
timeFrame: Changes from baselint at three and six months
measure: Microvascular reactivity
timeFrame: Changes from baselint at three and six months
measure: Body mass index
timeFrame: Changes from baselint at three and six months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation.
Study officials:
affiliation: Evandro Chagas National Institute of Infectious Disease
name: Fernanda Mendes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.