RecruitingNAINTERVENTIONAL

EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)

This study, called ExTASI-B, is investigating if doing brisk walking at home for 12 weeks can help people with Axial Spondyloarthritis (AxSpA) who are already on biologic medication. Researchers want to see if this exercise can further reduce their symptoms, improve their overall well-being, and lower inflammation in the body. They will compare a group who exercises with a group who continues their usual care. This research aims to understand if exercise can be an important extra treatment to help people with AxSpA manage their condition even better and improve their lives. It will also look at how acceptable this exercise plan is to patients.

At a glance

Status

Recruiting

Phase

Sponsor

Loughborough University

Enrolment target

Start

01 Aug 2024

Estimated completion

31 Jul 2029

Axial Spondyloarthrithis Inflammatory Diseases Arthritis

What is this study about?

This study is looking into a condition called Axial Spondyloarthritis, often shortened to AxSpA. It's a type of arthritis that mainly affects the spine but can also involve other joints. Many people with AxSpA feel pain, stiffness, and tiredness. Even though there are good medicines available, like biologics, doctors are always looking for more ways to help people live better with the condition.

This particular study wants to find out if adding a simple home-based exercise plan – specifically, brisk walking – can make an extra difference for people with AxSpA who are already taking biologic medications. Researchers believe that regular exercise might help reduce the inflammation that causes many of the symptoms in AxSpA. They will be comparing two groups of people with AxSpA: one group will do the exercise, and the other will continue with their regular care.

The main goal is to see if exercising helps to reduce inflammation in the body, lessen symptoms, and improve quality of life. The study will also explore how people taking part feel about the exercise plan, how it affects their fitness, and how their general health markers change. By understanding this, the study hopes to show whether exercise can be a valuable extra tool in managing AxSpA.

Key takeaways

This study explores how brisk walking might help people with AxSpA on biologic medication.
It aims to see if exercise can reduce symptoms, inflammation, and improve quality of life.
Participation involves 12 weeks of either home exercise or usual care.
You'll need to visit Loughborough University every four weeks for blood tests and questionnaires.
The study compares an exercise group to a usual care group, plus healthy controls.
Important for adults (18+) with an AxSpA diagnosis and stable biologic treatment.

Who may be eligible?

To join this study if you have Axial Spondyloarthritis, you need to be an adult (18 or older) and already have a diagnosis of AxSpA from a rheumatologist. You should also be taking a stable dose of biologic medication.

It's important that you are generally healthy enough for exercise and don't have major heart problems or other conditions that would make exercise unsafe. You should also be able to commit to the study's schedule and communicate in English. Unfortunately, if you are pregnant, breastfeeding, or planning to become pregnant during the study, you won't be able to take part. Also, if you already do a lot of intense physical activity, this study might not be for you.

There's also a group of healthy volunteers needed for comparison. If you're a healthy adult between 18 and 65, not on long-term medication that affects inflammation, and free from infection, you might be suitable. However, you shouldn't have conditions like immune disorders or heart problems to join the healthy group.

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 have a diagnosis of Axial Spondyloarthritis from a rheumatologist?
Are you 18 years old or older?
Are you currently taking a stable dose of biologic medication for your AxSpA?
Can you commit to regular brisk walking and study visits?
Are you generally healthy enough for exercise and don't have major heart issues?
Are you not pregnant, breastfeeding, or planning a pregnancy during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study and have Axial Spondyloarthritis, you'll be assigned by chance to one of two groups. One group will do a home exercise plan: this involves 30 minutes of brisk walking, five days a week, for 12 weeks. The other group will continue with their usual care and daily activities.

Everyone in the study, whether in the exercise or usual care group, will need to visit Loughborough University every four weeks for 12 weeks. During these visits, you'll provide blood samples and fill out questionnaires to help the researchers understand how you're feeling and how your body is responding. The blood tests will help check for signs of inflammation and overall health. The total duration of active participation for everyone in the study will be 12 weeks.

Potential risks and benefits

Taking part in this study may offer several potential benefits. For those in the exercise group, you might find that the regular brisk walking helps to improve your symptoms, reduce stiffness, boost your mood, and improve your overall fitness and well-being. The study aims to see if it can also help to lower inflammation in your body. However, there's no guarantee that you will personally experience these benefits. Potential risks are generally low, as the exercise is brisk walking, but as with any exercise, there's a small chance of muscle soreness or minor injury. The blood tests involve a needle prick, which might cause a little discomfort or bruising. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

Loughborough University, National Centre for Sport and Exercise Medicine
Verified postcode
Loughborough, United Kingdom· Recruiting
University Hospitals of Leicester NHS trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is Axial Spondyloarthritis (AxSpA)?

Axial Spondyloarthritis is a type of arthritis that mainly causes pain and stiffness in your spine, but can also affect other joints and parts of your body. It's an inflammatory condition.

What kind of exercise is involved?

The exercise involves brisk walking for 30 minutes, five days a week, at home. Brisk walking means you're working a bit, but can still talk in short sentences.

Will I have to stop my current medication?

No, you need to be on a stable dose of your biologic medication to be eligible for this study. The study looks at exercise as an 'add-on' to your existing treatment.

How long will I need to be involved in the study?

Your active participation will last for 12 weeks, which includes your home exercise plan (if in that group) and your visits to Loughborough University.

What if I can't exercise due to pain or other reasons?

If you have physical or psychological reasons that prevent you from exercising safely, or if you have certain joint problems, you wouldn't be able to join the study.

How to find out more

Nicolette C Bishop, PhD

n.c.bishop@lboro.ac.uk 01509226385 Official trial record

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