Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study)

Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study)

Trials, September 2016

27590681

Fernanda de Souza Nogueira Sardinha Mendes, Andréa Silvestre Sousa, Fernando Cesar de Castro Cesar Souza, Vivian Liane Mattos Pinto, Paula Simplicio Silva, Roberto Magalhães Saraiva, Sergio Salles Xavier, Henrique Horta Veloso, Marcelo Teixeira Holanda, Andréa Rodrigues Costa, Fernanda Martins Carneiro, Gilberto Marcelo Sperandio Silva, Juliana Pereira Borges, Eduardo Tibirica, Roberta Olmo Pinheiro, Flávio Alves Lara, Alejandro Marcel Hasslocher-Moreno, Pedro Emmanuel Alvarenga Americano Brasil, Mauro Felippe Felix Mediano

The effects of exercise training on Chagas heart disease are still unclear. This study aimed to evaluate the effect of exercise training over functional capacity, cardiac function, quality of life, and biomarkers in Chagas heart disease. The PEACH study is a superiority randomized clinical trial which will include subjects who meet the following criteria: Chagas heart disease with a left ventricular ejection fraction below 45 % with or without heart failure symptoms; clinical stability in the last 3 months; adherence to clinical treatment; and age above 18 years. The exclusion criteria are: pregnancy; neuromuscular limitations; smoking; evidence of non-chagasic heart disease; systemic conditions that limit exercise practice or cardiopulmonary exercise test; unavailability to attend the center three times a week during the intervention period; and practitioners of regular exercise. The intervention group will perform an exercise training intervention three times per week during 6 months and will be compared to the control group without exercise. Both groups will undergo the same monthly pharmaceutical and nutritional counseling as well as standard medical treatment according to the Brazilian consensus on Chagas disease. The primary outcome is functional capacity based on peak exercise oxygen consumption during cardiopulmonary exercise testing. Secondary outcomes are: cardiac function; body composition; muscle respiratory strength; microvascular reactivity; cardiac rhythm abnormalities; autonomic function; biochemical; oxidative stress and inflammatory biomarkers; and quality of life. Subjects will be evaluated at baseline, and at 3 and 6 months after randomization. Thirty patients will be randomly assigned into exercise or control groups at a ratio of 1:1. Findings of the present study will be useful to determine if physical exercise programs should be included as an important additional therapy in the treatment of patients with Chagas heart disease. ClinicalTrials.gov ID: NCT02517632 (registered on 6 August 2015).