All studies
RecruitingNAINTERVENTIONAL

Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)

This study is investigating a new treatment called Remote Ischaemic Conditioning, or RIC, for people who have broken a hip. Hip fractures are very common and can lead to serious problems. RIC involves gently inflating a blood pressure cuff around an arm or leg for short periods. This brief squeeze doesn't cause harm but aims to kickstart the body's natural healing processes, potentially reducing inflammation and helping bones heal better. We want to see if RIC is safe, easy for patients to do, and practical to use in hospitals after hip fracture surgery. Participants will typically receive this treatment daily for up to 10 days while in hospital. We'll also be looking at overall health, recovery, and how long people stay in hospital. This initial study will help us understand if RIC could be a helpful treatment for many more people in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrolment target
12
Start
02 Aug 2024
Estimated completion
31 Dec 2025

What is this study about?

Breaking a hip is a very serious injury, often affecting older people. It can be a long road to recovery, and unfortunately, many people experience complications like infections or heart problems afterwards. In the UK, around 70,000 people break a hip each year, which shows how important it is to find new ways to help them recover better.

This study is looking at a promising new approach called Remote Ischaemic Conditioning (RIC). Imagine putting a blood pressure cuff on your arm or leg and having it gently inflate and deflate for short bursts – that's essentially what RIC is. It's meant to trigger your body's natural defenses, almost like giving your system a gentle workout. This process is thought to help reduce inflammation, improve blood flow to injured areas, and potentially help bones heal faster.

We want to find out if RIC is a safe and practical treatment for people recovering from a hip fracture. We'll be closely monitoring participants to see how they feel, if they can comfortably complete the treatment, and if it's something hospitals could easily offer in the future. We'll also collect information on things like how long people stay in hospital, if they have any complications, and their overall recovery.

Key takeaways

  • Exploring a gentle, cuff-based treatment called RIC for hip fracture recovery.
  • Aims to boost body's natural healing, reduce inflammation, and improve blood flow.
  • Focuses on safety, comfort, and how practical the treatment is in hospital.
  • Involves daily 40-minute sessions for up to 10 days while in hospital.
  • Could lead to better recovery for many patients with hip fractures in the future.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently broken their hip. You need to be able to understand the study and agree to take part in writing, and your doctor needs to agree that you're suitable for the study and can follow the instructions.

However, some conditions might mean you can't join. For example, if you have certain existing blood vessel problems in the arm or leg where the cuff would be placed, or if you have specific nerve conditions or skin problems in that area. Also, if you have certain uncontrolled heart conditions, recent severe heart problems or stroke, or a history of specific blood clots, you might not be able to take part.

Quick self-check
  • Are you 18 years old or older?
  • Have you recently broken your hip (within the last 7 days)?
  • Are you able to understand and agree to take part in the study?
  • Do you have any severe uncontrolled heart conditions or specific blood vessel issues in your arms or legs?
  • Have you had a recent stroke or heart attack (in the last 4 weeks)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you agree to take part, you'll receive the RIC treatment daily for about 40 minutes for up to 10 days, or until you leave the hospital, whichever comes first. This 'dosing' uses a special cuff that inflates and deflates on your arm or leg. We'll mostly be checking that the treatment is safe and comfortable for you. We'll also ask you to fill in some questionnaires and we'll take some blood pressure readings and blood samples. We'll keep track of things like how long you stay in hospital. After you leave the hospital, there will be a follow-up check-up around three months later to see how you're recovering. The total time you'd be actively involved with the treatment would be up to 10 days during your hospital stay, with one follow-up after that.

Potential risks and benefits

This study is an early step to see if RIC could be helpful for hip fracture recovery. There's no guarantee of direct benefit for you, but it's hoped that RIC might help reduce inflammation, improve blood flow, and aid bone healing, potentially leading to a better recovery. The main benefit is helping us learn if this gentle treatment is safe and practical for future patients. RIC is considered a low-risk procedure, similar to having your blood pressure taken. Potential risks are very small and would be explained to you in detail, but could include minor temporary discomfort or skin irritation from the cuff. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

  • Sheffield Teaching Hospitals NHS Foundation Trust
    Sheffield, United Kingdom· Recruiting

Common questions

What is Remote Ischaemic Conditioning (RIC)?

RIC is a treatment that uses a blood pressure cuff on your arm or leg. The cuff inflates and deflates gently for short periods, aiming to trigger your body's natural healing responses.

Will the treatment hurt?

The cuff inflation feels similar to having your blood pressure taken. It shouldn't hurt, but you might feel a squeezing sensation. We will monitor your comfort closely.

How long will I have the treatment?

You will typically have the treatment once a day for about 40 minutes, for up to 10 days, while you are recovering in the hospital.

What happens after I leave the hospital?

We would like to check on your recovery around three months after you leave the hospital to see how you are doing.

Is RIC a new treatment?

RIC has been studied in other areas of medicine, but this is an early study to see if it's safe and useful specifically for people recovering from hip fractures.

How to find out more

Sarah Wilkinson

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

Interested in taking part?

Register your interest

Share your details and the research team for "Remote Ischaemic Conditioning for Post-surgical Complication…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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