RecruitingInterventional

RICFAST 2: A study on treating post-stroke fatigue

The RICFAST 2 study is looking into a common problem after a stroke: feeling extremely tired, known as post-stroke fatigue, which doesn't get better with rest. This tiredness can greatly impact recovery and daily life. Researchers want to see if a treatment called Remote Ischaemic Conditioning (RIC), which uses a standard blood pressure cuff, can help. The idea is that RIC might improve how our body's cells produce energy and how blood flows to different organs. This study hopes to find new ways to help stroke survivors feel more energetic and improve their quality of life.

At a glance

Status

Recruiting

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

15 Apr 2025

Estimated completion

23 May 2027

Post-stroke fatigue

What is this study about?

Many people who have had a stroke often feel very tired, a condition known as post-stroke fatigue. This isn't just regular tiredness; it's an overwhelming exhaustion that doesn't go away even after a good rest. This kind of fatigue can make it really hard to get back to normal life, enjoy hobbies, or connect with friends and family.

This study, called RICFAST 2, is set up to explore a new way to tackle this severe tiredness. The treatment they're investigating is called Remote Ischaemic Conditioning, or RIC for short. It's a simple process that involves using a standard blood pressure cuff, similar to what a nurse uses, on your arm. The cuff inflates and deflates at specific times. The researchers believe this might help your body's cells produce energy more efficiently and improve blood flow, which could lead to feeling less tired.

The main goal of this study is to find out if RIC truly can help reduce post-stroke fatigue. If it works, it could offer a new, straightforward treatment to improve the health and recovery of many stroke survivors, helping them regain their energy and get more out of life.

Key takeaways

RICFAST 2 studies a simple blood pressure cuff treatment (RIC) for post-stroke fatigue.
Aims to reduce overwhelming tiredness experienced by many stroke survivors.
Involves 60 participants, randomly assigned to different RIC treatment schedules.
Assessments over 6 months, mostly remote, with travel expenses covered for in-person visits.
Potential benefits include contributing to new knowledge and possible personal fatigue improvement.
Risks are generally minor, mainly discomfort from the cuff or blood tests.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, who has experienced a stroke at least 12 weeks ago. A key part is that you must have been experiencing significant and constant feelings of tiredness for at least six weeks that don't go away with rest. You also need to be able to fully understand what the study involves and agree to take part.

There are some reasons why you might not be able to join. For example, if you have certain existing health conditions like known causes of tiredness (such as severe sleep apnoea, active thyroid problems, or some types of cancer). You also can't take part if you've recently been in hospital for heart or brain-related issues, or if you're taking part in another clinical trial at the same time. If you have severe difficulties with speaking or thinking that would make it hard to understand the treatment or fill out forms, you might not be suitable. Also, if you are pregnant, trying to get pregnant, or have previously used RIC, you wouldn't be able to participate. They'll also check your arms to make sure there are no issues that would make using the cuff difficult.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you have a stroke at least 12 weeks ago?
Have you been feeling very tired and exhausted for at least 6 weeks, even after rest?
Do you not have any other known medical reasons for your tiredness, like a severe thyroid problem or active cancer?
Are you able to understand the study information and give your consent to participate?
Are you not currently pregnant or trying to get pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of 60 people randomly assigned to one of four groups. This means you won't choose which group you're in, it's decided by chance, like flipping a coin. Each group will receive the RIC treatment differently – some will have it three times a week for 6 weeks, others five times a week for 6 weeks, or three times a week for 12 weeks. The cuff pressure will also vary between groups.

The RIC treatment itself involves using a blood pressure cuff on your arm. You'll likely learn how to use it at home most of the time. You'll have several check-ups over six months, including at the start, at 6 weeks, 3 months, and 6 months. During these visits, you'll complete tests to measure your fatigue levels, how well you can move, and how your body's cells produce energy. Most of these visits will be done remotely (from your home) where possible, but some may be face-to-face. If you need to travel for face-to-face visits, your travel costs will be covered. The researchers are also flexible about fitting in tests, allowing you to spread them out over several visits or complete some questionnaires at home if needed, to make it easier for you. The study is expected to run from July 2024 to October 2027.

Potential risks and benefits

By taking part, you'll be helping researchers learn more about post-stroke fatigue and how RIC might help. If RIC is found to be effective, you might personally benefit from improved energy and recovery during the study. While RIC is generally considered safe, some minor side effects from the blood pressure cuff might include temporary pain or discomfort, a headache, small red spots on the skin (petechiae), tingling or numbness in your arms, or a change in arm colour. If you're part of a smaller group that has extra tests, there's a small chance of bruising or pain from blood tests, or discomfort from exercise tests. For MRI scans, strict safety checks are in place to ensure your safety, especially if you have metal implants. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
City only
Doncaster, United Kingdom
The Rotherham NHS Foundation Trust
City only
Rotherham, United Kingdom
Barnsley Hospital NHS Foundation Trust
City only
Barnsley, United Kingdom

Common questions

What is Remote Ischaemic Conditioning (RIC)?

RIC is a simple treatment that uses a standard blood pressure cuff on your arm. The cuff inflates and deflates at set times to briefly restrict blood flow, then release it.

Will I know if I'm getting the active treatment?

No, because the study assigns you to a group by chance, you won't know which specific treatment schedule you're on. This helps ensure the results are fair and accurate.

How often will I need to see the study team?

You'll have assessments at the start, at 6 weeks, 3 months, and 6 months. Many of these can be done remotely from your home to minimise travel.

Who is paying for this research?

This study is funded by The Stroke Association in the UK, a charity dedicated to supporting stroke survivors and research.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without impacting your regular medical care. Your decision will be respected.

How to find out more

Ali Ali

ali.ali@sheffield.ac.uk +44 114 2159154 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.