title: Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).
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.
  
  
  
  ClinicalTrials.gov ID: NCT02517632 (registered on 6 August 2015).
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil. fernanda.sardinha@ini.fiocruz.br.
authors: Fernanda de Souza Nogueira Sardinha
authors: Fde S
authors: Mendes
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Andréa Silvestre
authors: AS
authors: Sousa
authors: National Institute of Cardiology, Rua das Laranjeiras 374, Laranjeiras, Rio de Janeiro, 22240-006, Brazil.
authors: Fernando Cesar de Castro Cesar
authors: FC
authors: Souza
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Vivian Liane Mattos
authors: VL
authors: Pinto
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Paula Simplicio
authors: PS
authors: Silva
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Roberto Magalhães
authors: RM
authors: Saraiva
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Sergio Salles
authors: SS
authors: Xavier
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Henrique Horta
authors: HH
authors: Veloso
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Marcelo Teixeira
authors: MT
authors: Holanda
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Andréa Rodrigues
authors: AR
authors: Costa
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Fernanda Martins
authors: FM
authors: Carneiro
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Gilberto Marcelo Sperandio
authors: GM
authors: Silva
authors: National Institute of Cardiology, Rua das Laranjeiras 374, Laranjeiras, Rio de Janeiro, 22240-006, Brazil.|Physical Education and Sports Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, Maracanã, Rio de Janeiro, 20550-900, Brazil.|Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro, 21040-360, Brazil.
authors: Juliana Pereira
authors: JP
authors: Borges
authors: National Institute of Cardiology, Rua das Laranjeiras 374, Laranjeiras, Rio de Janeiro, 22240-006, Brazil.|Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro, 21040-360, Brazil.
authors: Eduardo
authors: E
authors: Tibirica
authors: Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro, 21040-360, Brazil.
authors: Roberta Olmo
authors: RO
authors: Pinheiro
authors: Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro, 21040-360, Brazil.
authors: Flávio Alves
authors: FA
authors: Lara
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Alejandro Marcel
authors: AM
authors: Hasslocher-Moreno
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Pedro Emmanuel Alvarenga Americano
authors: PE
authors: Brasil
authors: Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.
authors: Mauro Felippe Felix
authors: MF
authors: Mediano
mesh_terms: D015415:Biomarkers / Q000097:blood; D001938:Brazil; D000072038:Cardiac Rehabilitation / Q000009:adverse effects / Q000379:methods*; D002598:Chagas Cardiomyopathy / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D002985:Clinical Protocols; D005080:Exercise Test; D005081:Exercise Therapy / Q000009:adverse effects / Q000379:methods*; D017079:Exercise Tolerance; D006801:Humans; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013318:Stroke Volume; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D015415:Biomarkers
keywords: Cardiac rehabilitation; Cardiopulmonary exercise test; Chagas heart disease; Exercise training; Heart failure