Clinical Research Directory

Remote Ischaemic Conditioning for Fatigue After Stroke 2 (RICFAST 2)

Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Summary

Post-stroke fatigue is an overwhelming tiredness or lack of energy that does not get better with rest. It affects around half of people who have had a stroke. It can hold back recovery, make it harder to take part in everyday and social activities or to return to work, and reduce quality of life. There are currently no proven treatments for it. Remote ischaemic conditioning (RIC) is a simple treatment that people can do at home using a blood pressure cuff on the upper arm. The cuff is inflated for 5 minutes and then let down for 5 minutes, and this is repeated 4 times, taking about 40 minutes in all. RIC briefly and safely reduces blood flow to the arm before letting it return. Research suggests this may help the body's cells produce energy more efficiently, improve blood flow and reduce inflammation. In our earlier small study (RICFAST), RIC done 3 times a week for 6 weeks was safe and well tolerated, and there were early signs that it might reduce fatigue. This study (RICFAST 2) will find out: * whether people with post-stroke fatigue can safely and comfortably do RIC at home more often (5 times a week) or for longer (12 weeks) * whether enough people can be recruited to a study like this * whether doing RIC more often or for longer might reduce fatigue more, and for longer, than the usual schedule or a comparison treatment * how RIC might work in the body Who can take part? Adults who had a stroke between 3 months and 3 years ago and who have had troublesome fatigue for at least 6 weeks. People are being identified through stroke services, GP practices and community organisations in Sheffield, Doncaster, Rotherham and Barnsley (South Yorkshire, England). What does the study involve? 60 people will take part. Each person will be put into one of four groups by chance (randomisation), with 15 people in each group. The groups differ in the pressure the cuff is inflated to (called "Pressure 1" and "Pressure 2"), and in how often and for how long the treatment is done: * Group A (comparison group): cuff inflated to Pressure 1, 3 times a week for 6 weeks * Group B: cuff inflated to Pressure 2, 3 times a week for 6 weeks * Group C: cuff inflated to Pressure 2, 5 times a week for 6 weeks * Group D: cuff inflated to Pressure 2, 3 times a week for 12 weeks All the treatments cause a feeling of pressure in the upper arm. So that the results are fair, participants will not be told which cuff pressure is expected to have an effect. Everyone will continue with their usual care. Participants will be shown how to use the cuff at home, can do the treatment at any time of day, and will keep a simple treatment log and symptom diary. The research team will phone or video call each week to check how things are going. Each participant will also wear a wrist activity tracker (Fitbit) throughout the study to record their steps, activity and sleep. Questionnaires and tests of fatigue, mood, independence in daily activities, quality of life and walking will be done at the start of the study and 6 weeks, 12 weeks and 24 weeks (about 6 months) after starting treatment. The first three assessments take place at Sheffield Teaching Hospitals, and the 24-week assessment can be done remotely. Travel expenses are paid. Thirty participants from Groups A, B and C will be invited to have extra tests before treatment and after 6 weeks: an exercise test on a bike, a magnetic resonance (MRI) scan of the lower leg muscles to measure how much energy is stored in the muscle, and a blood test for markers of inflammation. Some participants will also be invited to an interview about their experience of doing the treatment at home. What do investigators expect to find? Investigators expect that people in all groups will be able to do the treatment at home, and that RIC done more often or for longer will lead to bigger and longer-lasting improvements in fatigue. The findings will be used to design a larger trial to test whether RIC is an effective treatment for post-stroke fatigue.

Official title: Remote Ischaemic Conditioning for Fatigue After Stroke 2 (RICFAST 2) - A Multi-arm, Randomised Controlled Feasibility Trial

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