Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial.

Autor: da Silva Rodrigues JC; Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., Luvizutto GJ; Department of Applied Physiotherapy, Triangulo Mineiro Federal University, Uberaba, Brazil., da Costa RDM; Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., Prudente RA; Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., da Silva TR; Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., de Souza JT; Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University, District of Rubião Junior, Botucatu, SP, 18618-687, Brazil., da Silveira CFDSMP; Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University, District of Rubião Junior, Botucatu, SP, 18618-687, Brazil., Rossi DAA; Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University, District of Rubião Junior, Botucatu, SP, 18618-687, Brazil., Winckler FC; Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., Modolo GP; Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., Valadão TFC; Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University, District of Rubião Junior, Botucatu, SP, 18618-687, Brazil., de Oliveira Antunes LC; Department of Rehabilitation, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., Martin LC; Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University, District of Rubião Junior, Botucatu, SP, 18618-687, Brazil., Bazan R; Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), São Paulo State University, São Paulo, Brazil., Bazan SGZ; Department of Internal Medicine, Botucatu Medical School (UNESP), São Paulo State University, District of Rubião Junior, Botucatu, SP, 18618-687, Brazil. sgzanati@fmb.unesp.br.
Jazyk: angličtina
Zdroj: Trials [Trials] 2019 May 28; Vol. 20 (1), pp. 298. Date of Electronic Publication: 2019 May 28.
DOI: 10.1186/s13063-019-3328-1
Abstrakt: 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 maxVO 2 ) 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.
Databáze: MEDLINE
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