Evidence map›Paper›PMID 36949443›Full record

ArticleTrials2023

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

Juli Thomaz de Souza, Marcos F Minicucci, Natália C Ferreira, Bertha F Polegato, Marina Politi Okoshi, Gabriel P Modolo, Bethan E Phillips, Philip J Atherton, Kenneth Smith, Daniel Wilkinson and 9 more

Open access · goldFull text readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 51% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 2 institutions in 2 countries.

Juli Thomaz de SouzaDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil. jtsouz@yahoo.com.br.ORCID http://orcid.org/0000-0003-2227-7505
Marcos F MinicucciDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Natália C FerreiraDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Bertha F PolegatoDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Marina Politi OkoshiDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Gabriel P ModoloDepartment of Neurology, Psychology and Psychiatry, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Bethan E PhillipsCentre for Musculoskeletal Ageing Research & NIHR Nottingham BRC Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre Uttoxeter Road, Derby, England.
Philip J AthertonCentre for Musculoskeletal Ageing Research & NIHR Nottingham BRC Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre Uttoxeter Road, Derby, England.
Kenneth SmithCentre for Musculoskeletal Ageing Research & NIHR Nottingham BRC Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre Uttoxeter Road, Derby, England.
Daniel WilkinsonCentre for Musculoskeletal Ageing Research & NIHR Nottingham BRC Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre Uttoxeter Road, Derby, England.
Adam GordonCentre for Musculoskeletal Ageing Research & NIHR Nottingham BRC Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre Uttoxeter Road, Derby, England.
Suzana E TanniDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Vladimir Eliodoro CostaStable Isotopes Center, Institute of Biosciences, São Paulo State University (UNESP), Botucatu, SP, Brazil.
Maria Fernanda P FernandesDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Silméia G Zanati BazanDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Leonardo A M ZornoffDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Rodrigo BazanDepartment of Neurology, Psychology and Psychiatry, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Sérgio A Rupp de PaivaDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Paula Schmidt AzevedoDepartment of Internal Medicine, São Paulo State University (UNESP) Medical School, Botucatu, SP, Brazil.
Universidade Estadual Paulista (Unesp) · BRUniversity of Nottingham · GB

Funding

Medical Research Council MR/P021220/1
6 · The paper itself

Abstract

backgroundStroke 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.

methodsRandomized, 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 registrationThe Brazilian Clinical Trials Registry (ReBEC) RBR-9q7gg4 . Registered on 21 January 2019.

Indexed as

CreatineStrokeDietary SupplementsDouble-Blind MethodHand StrengthHumansMusclesMuscle StrengthPostural BalanceQuality of LifeRandomized Controlled Trials as TopicTime and Motion StudiesTreatment OutcomeCreatineCreatineSarcopeniaSkeletal muscleStroke

Identifiers

PMID36949443
PMCPMC10035196
OpenAlexW4353057613

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read13
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.