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

Trials
January 1, 1970
Juli Thomaz de Souza et al. (19 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of maltodextrin (as a placebo) versus creatine supplementation on functional capacity, strength, and muscle mass changes in stroke patients during hospitalization.

Results Summary

The study did not report specific outcomes for maltodextrin alone, as it was used as a placebo control. The focus was on creatine supplementation, with no adverse effects or significant benefits attributed to maltodextrin.

Population

Individuals with acute ischemic stroke during hospitalization.

Effective Dosage

10g twice daily.

Duration

7 days.

Interactions

None mentioned.

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
creatine supplementation
neutral
functional capacity, strength, and changes in muscle mass
individuals with ischemic stroke in the acute phase
-
verify the effectiveness
#1
creatine supplementation
neutral
inflammatory profiles
all participants
-
assess
#2
creatine supplementation
neutral
functional capacity, muscle strength, mortality, and quality of life
individuals with ischemic stroke in the acute phase
-
verify
#3
powdered milk protein serum isolate supplementation
neutral
protein intake
patients with stroke
1.5g of protein/kg of body weight/day
achieve the goal
#4
daily physiotherapy
neutral
-
patients with stroke
-
according to the current rehabilitation guidelines
#5
Abstract

BACKGROUND: 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.

Medical Subject Headings (MeSH)
HumansCreatineHand StrengthQuality of LifePostural BalanceTime and Motion StudiesMuscle StrengthStrokeDietary SupplementsMusclesDouble-Blind MethodTreatment OutcomeRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy50/10
Quality80/10
Citation Metrics
Total Citations1
Citations/Year0.5
Relative Citation Ratio0.32
NIH Percentile16.9%
Research Impact Scores
APT Score0.50
Weight Score1.43
Normalized Score0.56
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Influence of CReatine supplementation on mUScle mass and str... | Panacea Index