RICFAST 2

• Research type

  Research Study

• Full title

  Remote Ischaemic Conditioning for Fatigue After Stroke – RICFAST 2. A multi-arm, randomised controlled feasibility study.

• IRAS ID

  349042

• Contact name

  Ali Ali

• Contact email

  ali.ali@sheffield.ac.uk

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  Approximately half of stroke survivors experience post-stroke fatigue (PSF): a feeling of exhaustion and lack of energy that does not improve with rest. They report PSF as one of their most troublesome symptoms affecting recovery, social engagement and quality of life.

  Remote Ischaemic Conditioning (RIC), a simple, self-delivered treatment whereby a blood pressure cuff is used to stop the flow of blood to the arm for 5-minute intervals, may reduce inflammation, increase energy activity of cells, and improve blood flow to different organs. This may counteract the effects of PSF.

  In a study of 24 people with PSF, training people to do RIC at home, 3 times a week for 6 weeks, was safe, well tolerated and appeared to improve PSF. Exercise testing and muscle MRI scanning suggested that RIC enhanced the efficiency of energy production in muscle cells.

  Now we want to see if people can tolerate a higher intensity and longer duration of RIC, and further explore how RIC works and which type of fatigue it is most effective for (e.g. physical or mental fatigue).

  Design and Methods

  We will recruit 60 people with PSF from 2 UK cities, randomised into 4 groups:

  • Group 1 (control group): ‘sham’ RIC (mild cuff inflation only) 3x/week for 6 weeks
  • Group 2: RIC (3x/week for 6 weeks)
  • Group 3: Intense RIC (5x/week for 6 weeks)
  • Group 4: Long RIC (3x/week for 12 weeks)

  We will measure fatigue and its sub-types (physical, mental and psychosocial symptoms), physical function (exercise testing) and cellular energetics (muscle MRI scanning) at baseline, 6 weeks, 3 months and 6 months, to understand:

  1. If a more intense or longer duration of RIC are feasible and if they appear to result in greater improvements in fatigue than regular RIC and control
  2. If the benefits last beyond stopping treatment (6 months)
  3. If we can characterise the type of fatigue people with PSF experience and if this influences their response to RIC
  4. How RIC works
  5. How physical activity is related to fatigue using smart wearable technology
  

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  25/YH/0006

• Date of REC Opinion

  20 Jan 2025

• REC opinion

  Favourable Opinion