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Remote Ischemic Conditioning for Fatigue After Stroke - RICFAST

  • Research type

    Research Study

  • Full title

    Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a pilot, single-blind, randomised, placebo controlled trial.

  • IRAS ID

    245385

  • Contact name

    Ali Ali

  • Contact email

    ali.ali@sth.nhs.uk

  • Sponsor organisation

    Sheffield Teaching Hospitals NHS FT

  • Clinicaltrials.gov Identifier

    STH19508, STH number

  • Duration of Study in the UK

    3 years, 0 months, 3 days

  • Research summary

    Remote ischaemic conditioning (RIC) is a when ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. These changes often result in improved collateralisation of blood supply to various areas of the body as well as improved efficiencies of cellular metabolism.This may have enhancing effects on physical abilities of patients undergoing rehabilitation after stroke, particularly when aiming to improve endurance and fatigue. Fatigue affects can affect up to 75% of patients who suffer a stroke [Wu et al 2014], which can be physical, cognitive or emotional, and can be a large barrier to progressing rehabilitation among such patients.

    In this pilot randomised controlled trial, 34 patients who have suffered an ischaemic or haemorrhagic stroke who suffer from fatigue, will be recruited and randomised to receive either RIC or sham intervention protocols for 6 weeks (1 session of 4 cycles three times weekly). Each session will take approximately 40 minutes and will be administered by a post-graduate researcher.

    The aim of this study is to assess if stroke patients undergoing rehabilitation find it acceptable to undertake chronic remote ischaemic conditioning (CRIC) for a period of 6 weeks. Also to establish if it is feasible to undertake a randomised control trial of CRIC to reduce fatigue and enhance the physical performance of patients undergoing rehabilitation following stroke?

    The design is a pilot, double blind, randomised, placebo controlled trial within a single centre.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    18/NW/0401

  • Date of REC Opinion

    22 Aug 2018

  • REC opinion

    Further Information Favourable Opinion