RecruitingNAINTERVENTIONAL

Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm

This study is a pilot, which means it's a small-scale trial to see if a program before surgery can help people recover better. We're looking at patients having a big operation for a condition called an abdominal aortic aneurysm, which is when the main blood vessel in the tummy swells up. Some patients will take part in a 'pre-habilitation' program, which involves nutrition advice and exercises, before their surgery. Others won't have this program. We'll then compare how well both groups recover in the 3 months after their operation, checking things like their daily activities and overall well-being. The goal is to see if preparing for surgery makes a real difference.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

Start

06 Dec 2022

Estimated completion

01 Jun 2025

Abdominal Aortic Aneurysm

What is this study about?

Imagine your body's main blood vessel in your tummy has a weak, bulging spot, like a balloon. This is called an abdominal aortic aneurysm (AAA). If it grows too large, doctors might recommend a major operation to fix it. This surgery is quite serious, especially for people in their 70s, and it can take time to recover afterwards.

This study wants to find out if preparing your body for this big surgery can help you recover faster and better. It's like training for a marathon, but instead, you're training for an operation. This preparation, called 'pre-habilitation', includes advice on eating well to keep your muscles strong, learning some simple exercises with a physiotherapist to build strength, and improving your fitness.

We'll be comparing two groups of people having this operation. One group will go through this special pre-habilitation program before surgery. The other group will have the usual care. By comparing them, we hope to learn if this pre-surgery preparation makes a real difference in how quickly people can get back to their normal daily activities and feel independent again after such a major procedure.

Key takeaways

This study explores if pre-surgery preparation helps recovery from AAA surgery.
Pre-habilitation involves diet advice and exercise before a major operation.
It aims to improve strength and fitness to aid recovery.
You might be asked to complete questionnaires after surgery.
Participation involves about 6-8 months in total.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for people who need to have an operation for an abdominal aortic aneurysm. This means the main blood vessel in your tummy has swelled up, and your doctors have decided it needs fixing with traditional open surgery. Your aneurysm should be a certain size (between 50-55mm) for you to be included.

There are also some reasons why you wouldn't be able to join. If your aneurysm needs urgent surgery, meaning there isn't enough time (at least 6 weeks) to do the pre-habilitation program, then this study wouldn't be suitable for you. The study aims to include both men and women between the ages of 18 and 100.

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.

Do you need open surgery for an abdominal aortic aneurysm (AAA)?
Is your aneurysm between 50-55mm in size?
Do you have at least 6 weeks before your scheduled surgery?
Are you between 18 and 100 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll either be in the 'pre-habilitation' group or the 'usual care' group. If you're in the pre-habilitation group, about 6 to 8 weeks before your surgery, you'll have a special visit with a rehabilitation doctor. They will assess your current fitness, work out a personal exercise plan, and talk about healthy eating. You'll then follow this plan at home, which includes nutrition advice and exercises to build muscle and improve your fitness.

After your surgery, whether you were in the pre-habilitation group or the usual care group, you'll have regular follow-up appointments with your surgeon as part of your standard care. In addition, you'll be asked to complete some questionnaires about your health, daily activities, and quality of life at 3 months and 6 months after your operation. There are no study medications involved. The total duration of your active participation, including the pre-surgery program and follow-up questionnaires, will be about 6 to 8 months.

Potential risks and benefits

Taking part in this study could potentially help you recover more quickly and feel stronger after your major surgery, by preparing your body beforehand. There are no known serious risks directly from the pre-habilitation program itself, which focuses on safe exercises and good nutrition. However, as with any medical study, there's always a small chance that the results might not be what's expected, or that participation might take up some of your time. You are completely free to withdraw from the study at any time, for any reason, and this will not affect the medical care you receive.

Locations (1)

Uh Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is an abdominal aortic aneurysm (AAA)?

It's a bulge or swelling in the main blood vessel that runs through your tummy. It can be serious if it gets too big.

What does 'pre-habilitation' mean?

It's a programme of exercises and nutritional advice that you do before a big operation to help your body prepare and recover better.

Do I have to do all the exercises alone?

You'll have an initial session with a physiotherapist to learn the exercises, and then you'll continue them independently at home.

How long will the study last for me?

Your active involvement, including the pre-surgery program and follow-up questionnaires, will be about 6 to 8 months in total.

What if I change my mind about participating?

You can leave the study at any point without it affecting your medical care.

How to find out more

Aurélien Hostalrich, MD

hostalrich.a@chu-toulouse.fr 05 61 32 26 20 Official trial record

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