Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial
Josiela Cristina da Silva Rodrigues,
Gustavo José Luvizutto,
Rafael Dalle Molle da Costa,
Robson Aparecido Prudente,
Taís Regina da Silva,
Juli Thomaz de Souza,
Caroline Ferreira da Silva Mazeto Pupo da Silveira,
Daniele Andreza Antonelli Rossi,
Fernanda Cristina Winckler,
Gabriel Pinheiro Modolo,
Tainá Fabri Carneiro Valadão,
Letícia Cláudia de Oliveira Antunes,
Luis Cuadrado Martin,
Rodrigo Bazan,
Silméia Garcia Zanati Bazan
Affiliations
Josiela Cristina da Silva Rodrigues
Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University
Gustavo José Luvizutto
Department of Applied Physiotherapy, Triangulo Mineiro Federal University
Rafael Dalle Molle da Costa
Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University
Robson Aparecido Prudente
Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University
Taís Regina da Silva
Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University
Juli Thomaz de Souza
Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University
Caroline Ferreira da Silva Mazeto Pupo da Silveira
Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University
Daniele Andreza Antonelli Rossi
Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University
Fernanda Cristina Winckler
Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), São Paulo State University
Gabriel Pinheiro Modolo
Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), São Paulo State University
Tainá Fabri Carneiro Valadão
Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University
Letícia Cláudia de Oliveira Antunes
Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University
Luis Cuadrado Martin
Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University
Rodrigo Bazan
Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), São Paulo State University
Silméia Garcia Zanati Bazan
Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University
Abstract Background Cardiovascular rehabilitation is one of the treatment options for post-stroke individuals in order to improve functional independence in activities of daily life and reduce energy expenditure. The aim of this trial is to evaluate the effect of an exercise program on the echocardiographic variables, functional capacity, inflammatory response, neurological status, nutritional status, cardiologic evaluation, and quality of life of patients after stroke. Methods/design This is a randomized controlled trial including patients with ischemic stroke in the chronic phase. The patients will be evaluated at the beginning of the study and after 16 weeks. This will include clinical and physical evaluation, 6-min walk test, neurological assessment, nutritional assessment, ambulatory blood pressure monitoring, transthoracic echocardiography, and assessment of the quality of life. The sample size has been determined as 40 patients, who will be divided into two groups: control group (CG; n = 20) and intervention group (IG; n = 20). The CG will undergo conventional physiotherapy for 45 min, three times a week, up to 16 weeks, while the IG will be put on a cardiovascular rehabilitation program consisting of heating, aerobic exercise, and muscle strengthening for 45 min, three times a week, for 16 weeks. The primary endpoint will be functional capacity following a 6-min walk test (delta maxVO2) and morphofunctional echocardiographic variables (indexed left ventricular mass) before and after the intervention. Discussion We expect to observe an improvement in cardiac structural and functional abnormalities in the IG, on echocardiography and biochemical examination, and that the improvement of these parameters after cardiovascular rehabilitation will have a favorable impact on the functional capacity and quality of life of patients after stroke. Trial registration REBEC, RBR-4wk4b3. Registered on 19 September 2016.
