Not yet recruitingNAINTERVENTIONAL

An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study

This study aims to develop and test a safe exercise and lifestyle programme for adults living with vascular Ehlers-Danlos Syndrome (vEDS). vEDS is a rare health condition affecting connective tissue, and while people with vEDS are often advised to avoid physical activity, we don't fully understand how safe structured exercise is for them. Working closely with vEDS patients, their families, and doctors, we're creating a tailored exercise plan. We'll then test this plan over 12 weeks to see if it's safe, acceptable, and practical. The main goal is to gather information that will help design a larger study in the future. We'll be looking at things like how easy it is to recruit people, if they stick with the programme, and if there are any safety concerns, as well as how it might affect their physical health and quality of life.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Sheffield Hallam University

Enrolment target

Start

01 Mar 2027

Estimated completion

17 Mar 2028

Vascular Ehlers Danlos Syndrome

What is this study about?

Vascular Ehlers-Danlos Syndrome, often called vEDS, is a rare condition that affects the body's connective tissue. This tissue provides strength and support to many parts of the body, including blood vessels. For people with vEDS, their doctors have often advised them to avoid or limit physical activity due to concerns about safety. However, we don't really know enough about how safe and helpful a carefully planned exercise programme might be for them.

This study, called "An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study," aims to find out. Our main goal is to work together with people who have vEDS, their families, and their doctors to create an exercise and lifestyle programme that is both safe and tailored to their needs. We then want to test this programme in a smaller group of people to understand a few key things.

First, we want to see if it's possible to recruit enough people for the study and if they are happy to take part and follow the programme. Second, and very importantly, we want to check if the exercise programme is safe for people with vEDS and if they find it acceptable. This will help us decide if we can run a much larger study in the future to understand the full benefits of exercise for people with vEDS.

Key takeaways

This study explores safe exercise for adults with vEDS.
It aims to create a tailored exercise programme with patient input.
The 12-week study checks if the programme is safe and practical.
Information gathered will help plan future, larger studies.
Medical clearance from your doctor is essential if you wish to participate.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and live in the UK. You need to have a confirmed diagnosis of vascular Ehlers-Danlos Syndrome (vEDS) and be able to give your consent to take part. It's also important that your general health is stable. This means you shouldn't have had any major vEDS-related issues, like a serious problem with a blood vessel or a hospital stay for vEDS complications, in the last six months. Your blood pressure should also be well-managed by your doctor, and you should not be pregnant when you enrol.

Your doctor will need to confirm that you are medically fit enough to join the study. If you have had a major vEDS-related vascular event (like a problem with an artery) in the last six months, or if you've recently been in hospital for vEDS complications, or your blood pressure isn't controlled, then you wouldn't be able to join. Similarly, if you were pregnant when enrolling or unable to understand and agree to take part, you wouldn't be eligible. If you become pregnant during the study, you would stop the exercise part, but you could still choose to share your health information if you wish.

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?
Do you have a firm diagnosis of vascular Ehlers-Danlos Syndrome (vEDS)?
Are you currently living in the UK?
Is your health generally stable, with no recent serious vEDS-related issues or hospital stays?
Is your blood pressure well-controlled by your doctor?
Are you not pregnant at the time you would join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several steps over about 12 weeks. First, we will have conversations with people with vEDS, their family members, and doctors to understand their experiences with physical activity. Then, we will hold group discussions to design the exercise and lifestyle programme. If you are eligible and agree to join the main part of the study, you will be randomly placed into one of two groups: either the new exercise and lifestyle programme or receiving your usual care.

The new exercise programme is designed to be tailored to you. Throughout the 12 weeks, we will be collecting information about how well the programme works, whether it's safe, and if people find it acceptable. We will also look at how it might affect your physical abilities and overall well-being. After the 12-week programme, we will have follow-up interviews to hear about your experiences and help us improve the programme even further.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as gaining access to a specially designed exercise programme and contributing important information that could help others with vEDS in the future. However, there may also be risks associated with physical activity, particularly for people with vEDS, which is why safety is a primary focus of this study and why medical clearance from your doctor is needed. There is always the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sheffield Hallam University
Verified postcode
Sheffield, United Kingdom

Common questions

What is vEDS?

vEDS stands for vascular Ehlers-Danlos Syndrome. It's a rare condition that affects the body's connective tissues, particularly blood vessels, making them more fragile.

Why is exercise important for vEDS?

Doctors have traditionally advised limiting exercise for vEDS, but this study is trying to understand if a carefully designed exercise programme can be safe and beneficial. We want to find out more about this.

Will I have to do any specific exercises?

The study involves creating a co-designed exercise and lifestyle programme. This means it will be developed with input from people with vEDS, families, and doctors, so it will be tailored and safe.

What does 'feasibility study' mean?

A 'feasibility study' is a smaller study done first to see if a larger study would be possible. It checks if the plan is safe, practical, and acceptable before investing in a much bigger project.

How long will the study last if I take part?

The main part of the study involves a 12-week programme, but there are also initial discussions and interviews before and after this period.

How to find out more

Ian Thistlewood

i.thistlewood@shu.ac.uk +447939953194 Official trial record

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