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

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

Trials, December 2016, Vol. 17 Issue: Number 1 p1-11,

Abstract: 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.