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Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).
Trials. 2016 09 02; 17(1):433.T

Abstract

BACKGROUND

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.

METHODS

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.

DISCUSSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov ID: NCT02517632 (registered on 6 August 2015).

Authors+Show Affiliations

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.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.National Institute of Cardiology, Rua das Laranjeiras 374, Laranjeiras, Rio de Janeiro, 22240-006, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.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.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.Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro, 21040-360, Brazil.Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro, 21040-360, Brazil.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27590681

Citation

Mendes, Fernanda de Souza Nogueira Sardinha, et al. "Effect of Physical Exercise Training in Patients With Chagas Heart Disease: Study Protocol for a Randomized Controlled Trial (PEACH Study)." Trials, vol. 17, no. 1, 2016, p. 433.
Mendes Fde S, Sousa AS, Souza FC, et al. Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study). Trials. 2016;17(1):433.
Mendes, F. d. e. . S., Sousa, A. S., Souza, F. C., Pinto, V. L., Silva, P. S., Saraiva, R. M., Xavier, S. S., Veloso, H. H., Holanda, M. T., Costa, A. R., Carneiro, F. M., Silva, G. M., Borges, J. P., Tibirica, E., Pinheiro, R. O., Lara, F. A., Hasslocher-Moreno, A. M., Brasil, P. E., & Mediano, M. F. (2016). Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study). Trials, 17(1), 433. https://doi.org/10.1186/s13063-016-1553-4
Mendes Fde S, et al. Effect of Physical Exercise Training in Patients With Chagas Heart Disease: Study Protocol for a Randomized Controlled Trial (PEACH Study). Trials. 2016 09 2;17(1):433. PubMed PMID: 27590681.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study). AU - Mendes,Fernanda de Souza Nogueira Sardinha, AU - Sousa,Andréa Silvestre, AU - Souza,Fernando Cesar de Castro Cesar, AU - Pinto,Vivian Liane Mattos, AU - Silva,Paula Simplicio, AU - Saraiva,Roberto Magalhães, AU - Xavier,Sergio Salles, AU - Veloso,Henrique Horta, AU - Holanda,Marcelo Teixeira, AU - Costa,Andréa Rodrigues, AU - Carneiro,Fernanda Martins, AU - Silva,Gilberto Marcelo Sperandio, AU - Borges,Juliana Pereira, AU - Tibirica,Eduardo, AU - Pinheiro,Roberta Olmo, AU - Lara,Flávio Alves, AU - Hasslocher-Moreno,Alejandro Marcel, AU - Brasil,Pedro Emmanuel Alvarenga Americano, AU - Mediano,Mauro Felippe Felix, Y1 - 2016/09/02/ PY - 2016/04/21/received PY - 2016/08/13/accepted PY - 2016/9/4/entrez PY - 2016/9/4/pubmed PY - 2017/12/2/medline KW - Cardiac rehabilitation KW - Cardiopulmonary exercise test KW - Chagas heart disease KW - Exercise training KW - Heart failure SP - 433 EP - 433 JF - Trials JO - Trials VL - 17 IS - 1 N2 - BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02517632 (registered on 6 August 2015). SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/27590681/Effect_of_physical_exercise_training_in_patients_with_Chagas_heart_disease:_study_protocol_for_a_randomized_controlled_trial__PEACH_study__ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1553-4 DB - PRIME DP - Unbound Medicine ER -