Influence of CReatine supplementation on mUScle mass and strength after stroke (ICaRUS Stroke Trial): study protocol for a randomized controlled trial

Página do item simplificado
dc.contributor.authorde Souza, Juli Thomaz [UNESP]
dc.contributor.authorMinicucci, Marcos F. [UNESP]
dc.contributor.authorFerreira, Natália C. [UNESP]
dc.contributor.authorPolegato, Bertha F. [UNESP]
dc.contributor.authorOkoshi, Marina Politi [UNESP]
dc.contributor.authorModolo, Gabriel P. [UNESP]
dc.contributor.authorPhillips, Bethan E.
dc.contributor.authorAtherton, Philip J.
dc.contributor.authorSmith, Kenneth
dc.contributor.authorWilkinson, Daniel
dc.contributor.authorGordon, Adam
dc.contributor.authorTanni, Suzana E. [UNESP]
dc.contributor.authorCosta, Vladimir Eliodoro [UNESP]
dc.contributor.authorFernandes, Maria Fernanda P. [UNESP]
dc.contributor.authorBazan, Silméia G. Zanati [UNESP]
dc.contributor.authorZornoff, Leonardo A. M. [UNESP]
dc.contributor.authorBazan, Rodrigo [UNESP]
dc.contributor.authorde Paiva, Sérgio A. Rupp [UNESP]
dc.contributor.authorAzevedo, Paula Schmidt [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionUniversity of Nottingham
dc.date.accessioned2023-07-29T13:47:29Z
dc.date.available2023-07-29T13:47:29Z
dc.date.issued2023-12-01
dc.description.abstractBackground: Stroke is a leading cause of mortality and disability, and its sequelae are associated with inadequate food intake which can lead to sarcopenia. The aim of this study is to verify the effectiveness of creatine supplementation on functional capacity, strength, and changes in muscle mass during hospitalization for stroke compared to usual care. An exploratory subanalysis will be performed to assess the inflammatory profiles of all participants, in addition to a follow-up 90 days after stroke, to verify functional capacity, muscle strength, mortality, and quality of life. Methods: Randomized, double-blind, unicenter, parallel-group trial including individuals with ischemic stroke in the acute phase. The duration of the trial for the individual subject will be approximately 90 days, and each subject will attend a maximum of three visits. Clinical, biochemical, anthropometric, body composition, muscle strength, functional capacity, degree of dependence, and quality of life assessments will be performed. Thirty participants will be divided into two groups: intervention (patients will intake one sachet containing 10g of creatine twice a day) and control (patients will intake one sachet containing 10g of placebo [maltodextrin] twice a day). Both groups will receive supplementation with powdered milk protein serum isolate to achieve the goal of 1.5g of protein/kg of body weight/day and daily physiotherapy according to the current rehabilitation guidelines for patients with stroke. Supplementation will be offered during the 7-day hospitalization. The primary outcomes will be functional capacity, strength, and changes in muscle mass after the intervention as assessed by the Modified Rankin Scale, Timed Up and Go test, handgrip strength, 30-s chair stand test, muscle ultrasonography, electrical bioimpedance, and identification of muscle degradation markers by D3-methylhistidine. Follow-up will be performed 90 days after stroke to verify functional capacity, muscle strength, mortality, and quality of life. Discussion: The older population has specific nutrient needs, especially for muscle mass and function maintenance. Considering that stroke is a potentially disabling event that can lead the affected individual to present with numerous sequelae, it is crucial to study the mechanisms of muscle mass loss and understand how adequate supplementation can help these patients to better recover. Trial registration: The Brazilian Clinical Trials Registry (ReBEC) RBR-9q7gg4. Registered on 21 January 2019.en
dc.description.affiliationDepartment of Internal Medicine São Paulo State University (UNESP) Medical School, SP
dc.description.affiliationDepartment of Neurology Psychology and Psychiatry São Paulo State University (UNESP) Medical School, SP
dc.description.affiliationCentre for Musculoskeletal Ageing Research & NIHR Nottingham BRC Clinical Metabolic and Molecular Physiology University of Nottingham, Royal Derby Hospital Centre Uttoxeter Road
dc.description.affiliationStable Isotopes Center Institute of Biosciences São Paulo State University (UNESP), SP
dc.description.affiliationUnespDepartment of Internal Medicine São Paulo State University (UNESP) Medical School, SP
dc.description.affiliationUnespDepartment of Neurology Psychology and Psychiatry São Paulo State University (UNESP) Medical School, SP
dc.description.affiliationUnespStable Isotopes Center Institute of Biosciences São Paulo State University (UNESP), SP
dc.identifierhttp://dx.doi.org/10.1186/s13063-023-07248-6
dc.identifier.citationTrials, v. 24, n. 1, 2023.
dc.identifier.doi10.1186/s13063-023-07248-6
dc.identifier.issn1745-6215
dc.identifier.scopus2-s2.0-85150847864
dc.identifier.urihttp://hdl.handle.net/11449/248564
dc.language.isoeng
dc.relation.ispartofTrials
dc.sourceScopus
dc.subjectCreatine
dc.subjectSarcopenia
dc.subjectSkeletal muscle
dc.subjectStroke
dc.titleInfluence of CReatine supplementation on mUScle mass and strength after stroke (ICaRUS Stroke Trial): study protocol for a randomized controlled trialen
dc.typeArtigo
unesp.author.orcid0000-0003-2227-7505[1]
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Medicina, Botucatupt
unesp.departmentClínica Médica - FMBpt
unesp.departmentNeurologia, Psicologia e Psiquiatria - FMBpt

Arquivos

Coleções

Botucatu - FMB - Faculdade de Medicina