RecruitingInterventional

Rehabilitation after revascularisation surgery: a study to improve recovery

This research is for people who have had surgery to improve blood flow in their legs due to a condition called chronic limb-threatening ischemia (CLTI). CLTI is a severe form of peripheral artery disease, causing leg pain and sometimes tissue damage. Even after surgery, people with CLTI can face ongoing challenges with walking, fitness, and their general quality of life. This study will test a 12-week programme that includes supervised exercise sessions, home exercises, and educational talks. The aim is to find out if this type of rehabilitation can help people recover better, improve their physical ability, and reduce serious health risks after leg surgery. It could also help improve future care for others with similar conditions.

At a glance

Status

Recruiting

Sponsor

Manchester University NHS Foundation Trust

Enrolment target

Start

31 Mar 2026

Estimated completion

30 Apr 2027

Specialty: Cardiovascular, Primary sub-specialty: Cardiovascular; Health Category: Cardiovascular, Musculoskeletal; Disease/Condition: Diseases of arteries, arterioles and capillaries

What is this study about?

This study is looking into a health problem called chronic limb-threatening ischemia (CLTI). This is a serious condition where there isn't enough blood flowing to the legs and feet, often causing pain when walking or even at rest, and sometimes leading to open sores or wounds. It's becoming more common, and affects many people, especially those with diabetes or from certain ethnic backgrounds.

People with CLTI often need urgent surgery to get blood flowing to their legs again. However, even after this surgery, many still struggle. They might find it hard to walk, their fitness levels can be low, and they might experience anxiety or sadness. Sadly, they are also at higher risk of further health problems, including losing a limb or even death. This study wants to find out if a special exercise and education programme can help people recover better after their leg surgery, improve their physical health, and boost their overall well-being.

The research team has designed a 12-week programme that includes supervised exercise and educational sessions, along with exercises to do at home. While similar programmes have helped people after heart surgery, it's not known if they work as well for those who've had leg surgery for CLTI. This study will help us understand if this programme is helpful and how it could improve the care given to patients in the future.

Key takeaways

This study evaluates a 12-week exercise and education programme.
It's for people who have had leg artery surgery (revascularisation) for severe circulation problems (CLTI).
The goal is to improve recovery, fitness, and quality of life after surgery.
Participants will attend weekly supervised sessions and do home exercises.
Travel expenses are reimbursed, and a voucher is given on completion.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with chronic limb-threatening ischemia (CLTI). This means you have a serious problem with blood flow to your legs.

To join, you must have had surgery to improve the blood flow in your legs at least 4 weeks ago, but no longer than 3 months ago. You should also be physically able to take part in an exercise rehabilitation programme and be able to understand and agree to the study activities in English. You cannot join if you are waiting for another surgery or if you have unhealed wounds on your legs or feet.

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?
Have you been diagnosed with chronic limb-threatening ischemia (CLTI)?
Did you have leg surgery (revascularisation) between 4 weeks and 3 months ago?
Are you physically able to take part in an exercise programme?
Can you understand and speak English?
Are you NOT waiting for another surgery and do you NOT have open wounds on your legs/feet?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have an initial health check-up. After that, you'll start a 12-week rehabilitation programme. This involves visiting a study centre once a week for supervised exercise sessions. You'll also be given exercises to do at home. Every two weeks, there will be educational sessions about your condition. At the end of the 12 weeks, you'll have a final check-up to see how your mobility, health, and quality of life have improved. You might also be invited to have an informal chat about your experience, but this is optional. The total time you'll be involved in the study is about 12 weeks, plus the optional interview.

Potential risks and benefits

You might not get any direct benefits from joining this study. However, if any health issues are found during your checks, you will receive proper medical advice. You can also claim up to £60 for travel costs and will receive a £50 voucher if you complete the 12-week programme as a thank you. The study mainly involves gathering information and gentle measurements. There's a very small chance of feeling breathless during exercise tests, or experiencing some leg pain or muscle soreness from the exercise, which is normal. The research team is highly trained and will minimise any discomfort. If you find talking about your experiences upsetting during an interview, the team will stop recording and offer support. You are free to withdraw from the study at any time without giving a reason.

Locations (2)

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

Heartbeat (Preston)
City only
Preston, England
North West RRDN
City only
Manchester, England

Common questions

What is Peripheral Artery Disease (PAD) and CLTI?

PAD is a common condition where narrowed arteries reduce blood flow to your limbs, usually your legs. CLTI is a severe type of PAD where the lack of blood flow causes constant pain, even at rest, and can lead to wounds or infection.

What does 'revascularisation surgery' mean?

This is an operation, like a bypass or fitting a stent, to improve blood flow in the arteries of your legs that have become blocked or narrowed. It helps get more blood to your muscles and tissues.

Where are the study centres located?

The study is being run from Manchester Royal Infirmary in Manchester and the Heartbeat centre in Preston, UK.

When does the study start and how long will it last?

The study plans to start accepting participants in March 2026 and will continue until April 2027. Your involvement would last for 12 weeks.

Will I have to pay to take part?

No, you will not have to pay. In fact, you can claim up to £60 for travel expenses, and you will receive a £50 voucher for completing the main part of the study.

How to find out more

Stefan Birkett

s.birkett@mmu.ac.uk +44 0161 2472000 Official trial record

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