Active not recruitingNAINTERVENTIONAL

The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

The CardioFit Trial is exploring if an exercise programme, done before valve replacement surgery, is safe and possible for patients with severe aortic stenosis. Aortic stenosis means your heart valve is narrowed, making your heart work harder. We know that exercising after this type of surgery helps recovery, but less is known about exercising beforehand. This study aims to find out if getting fitter before surgery, through a structured exercise plan, can improve how well patients do after the operation. It's a small study to check if this approach is safe and that patients can stick to the plan.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

28 Jan 2025

Estimated completion

10 Dec 2025

Aortic Stenosis, Severe

What is this study about?

The CardioFit Trial is a study for people who need surgery to replace a narrowed heart valve, a condition called severe aortic stenosis. When this valve is narrowed, your heart has to work much harder to pump blood around your body. The good news is that replacing the valve can significantly improve your health.

We already know that taking part in exercise programmes after heart surgery, often called cardiac rehabilitation, can help people recover well. However, we're not as sure about exercising before this specific type of surgery, mainly because doctors want to make sure it's safe for people with severe aortic stenosis. This study aims to fill that gap.

The main goal of the CardioFit Trial is to see if a special exercise programme, done in the hospital before your operation, is safe and that you can comfortably take part in it. If we can show that getting fitter beforehand is both safe and possible, it could help patients have a smoother recovery and better results from their surgery. This trial is an important step towards understanding how to best prepare people for their heart valve operation.

Key takeaways

This study explores pre-surgery exercise for severe aortic stenosis.
It aims to see if an exercise programme before surgery is safe and possible.
Getting fitter before surgery might improve recovery.
Participation involves a supervised hospital-based exercise plan.
The study focuses on feasibility and safety, not on new medications.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have severe aortic stenosis. Your care team must have already decided that you need elective (planned) aortic valve replacement surgery, and this surgery shouldn't be scheduled for at least 14 days from when you might join the study.

There are also some reasons why you might not be able to join. For example, if your aortic stenosis is extremely severe with specific measurements, or if you've recently fainted or had chest pain because of your heart condition, you wouldn't be able to participate. Also, if you have certain serious heart rhythm problems, are pregnant, or weigh more than 160kg, you wouldn't be eligible.

Other reasons you might not be able to join include if you've decided not to have the surgery, are already in another similar study, or are unable to give your informed consent to take part. The team will carefully check all these points with you.

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 or older?
Have you been diagnosed with severe aortic stenosis?
Has your doctor planned for you to have aortic valve replacement surgery?
Is your surgery planned for at least two weeks from now?
Do you weigh less than 160kg?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will join a special exercise programme delivered at the hospital before your surgery. This programme is designed to help you get fitter. The study team will make sure the exercise is right for you and monitor you closely. They'll also check how well you stick to the programme and if you experience any unexpected issues.

The main goal is to understand if this exercise programme is something people can do and if it's safe. There won't be any new medication involved in this study, just the exercise programme. The total duration of your participation will be from when you start the exercise programme until your surgery.

Potential risks and benefits

Participating in this study might offer the benefit of potentially improving your physical fitness before your surgery, which could lead to a better recovery. However, as with any exercise, there's always a small risk of discomfort or other issues, especially with your heart condition. The study team will closely monitor you to ensure your safety and will adjust the exercise programme if needed. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

University Hopsitals Southampton NHS FT
Verified postcode
Southampton, United Kingdom

Common questions

What is severe aortic stenosis?

It's when the main valve in your heart that lets blood leave to your body becomes very narrowed, making your heart work extra hard.

What is this 'exercise training programme'?

It's a structured exercise plan, delivered in the hospital, designed to help you get fitter before your heart valve surgery.

Is exercising before heart surgery safe?

That's exactly what this study aims to find out! We'll carefully monitor participants to check if it's safe and tolerable.

How long will I be in the exercise programme?

The programme will run for a period leading up to your planned aortic valve replacement surgery.

Will I have to pay to join the study?

No, you will not have to pay to participate in the clinical trial.

How to find out more

Official trial record

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