Dataset Information

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

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).

SUBMITTER: Mendes Fde S

PROVIDER: S-EPMC5010675 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Publications

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 Fde S Sousa Andréa Silvestre AS Souza Fernando Cesar de Castro Cesar FC Pinto Vivian Liane Mattos VL Silva Paula Simplicio PS Saraiva Roberto Magalhães RM Xavier Sergio Salles SS Veloso Henrique Horta HH Holanda Marcelo Teixeira MT Costa Andréa Rodrigues AR Carneiro Fernanda Martins FM Silva Gilberto Marcelo Sperandio GM Borges Juliana Pereira JP Tibirica Eduardo E Pinheiro Roberta Olmo RO Lara Flávio Alves FA Hasslocher-Moreno Alejandro Marcel AM Brasil Pedro Emmanuel Alvarenga Americano PE Mediano Mauro Felippe Felix MF

Trials 20160902 1

<h4>Background</h4>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.<h4>Methods</h4>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 symp ...[more]

PMID: 27590681

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Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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