Remote Ischaemic Conditioning for Fatigue After Stroke 2
Official title: Remote Ischaemic Conditioning for Fatigue After Stroke 2 (RICFAST 2) - A Multi-arm, Randomised Controlled Feasibility Trial
Run by Sheffield Teaching Hospitals NHS Foundation Trust · NCT07914647 · Data updated 2026-11-12
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Status | Recruiting |
| Started | April 16, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07914647 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults ≥18 years with a history of ischemic or hemorrhagic stroke at least 12 weeks prior and clinically significant fatigue (mean FSS ≥4) who can consent and comply with procedures.
✕Probably not a fit
Patients with other major fatigue causes or recent cardiovascular events may not experience benefit and could be excluded from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 trial tests remote ischaemic conditioning (RIC) delivered at home versus sham RIC for adults with fatigue after stroke. Participants perform brief cuff inflations on the upper arm over about 40 minutes, three times per week for several weeks. The study builds on a prior small trial that suggested RIC was safe and might lessen fatigue. Outcomes focus on fatigue severity and functional recovery, with careful monitoring for safety. The trial is conducted at a single site in Sheffield, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust.
Why it matters
Potential benefit: If successful, RIC could offer a simple, at-home approach to reduce post-stroke fatigue and support rehabilitation.
How similar studies have gone: Earlier small studies suggested RIC was safe and may reduce fatigue, but robust evidence is still needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥ 18 years) with ischaemic or haemorrhagic stroke, at least 12 weeks prior * Symptoms of debilitating fatigue for at least 6 weeks (mean FSS ≥ 4). * Capacity to give informed consent. * Ability to comply with study procedures (see page 19) Exclusion Criteria: * Participation in another intervention trial * Significant peripheral vascular disease, neuropathy, ulceration or lymphadenopathy in the upper limbs * Hospitalisation for cardiovascular or cerebrovascular disease within the last 4 weeks (this may act as an ischaemic conditioning stimulus) * Known causes of fatigue e.g. obstructive sleep apnoea, depression, active thyroid disease, active cancer, MS, MND and PD * Severe aphasia or cognitive impairment that would preclude their understanding of learning to self-deliver the RIC intervention or complete the required outcome measures (e.g. MRI, exercise tests, questionnaires). We will use the Consent Support Tool (CST) to aid this judgement \[ref\]. * Pregnant or trying to get pregnant\* * Prior use of RIC
Where it's running
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Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom Recruiting
Study contacts
- Study coordinator: Ali N Ali, MBChB
- Email: ali.ali@sheffield.ac.uk
- Phone: +44 1142159114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.