RecruitingNAINTERVENTIONAL

Biofeedback Intervention for Paroxysmal Atrial Fibrillation

This project is exploring a new way to help people with an irregular heartbeat called paroxysmal atrial fibrillation (AF) improve their physical activity. Researchers are developing a system that uses smartwatches to track heart activity and movement. They will then send personalised text messages with feedback to encourage participants to be more active. The study has two parts: first, they'll work with patients to design and test how easy the smartwatch and messaging system is to use. Then, in the second part, they will see if it's practical to run a bigger study across the UK and if patients find the system useful. This will help them decide if this approach can be formally tested in a larger trial.

At a glance

Status

Recruiting

Phase

Sponsor

Liverpool John Moores University

Enrolment target

Start

15 Apr 2026

Estimated completion

01 Feb 2028

Atrial Fibrillation (Paroxysmal)

What is this study about?

This study is about helping people who have a specific type of irregular heartbeat called paroxysmal atrial fibrillation (AF). This means your heart sometimes beats irregularly, rather than all the time. The main goal is to find new ways to encourage people with this condition to be more physically active, as staying active can be really good for your heart and overall health.

The researchers are developing a special system that combines smartwatches with personalised text messages. The smartwatch will keep an eye on your heart rhythm and how much you move. Based on this information, you'll receive text messages that give you feedback and gentle nudges to increase your physical activity. This trial is checking whether this smart-tech approach is practical, easy to use, and helpful for patients, before it's used in a bigger study across the country.

The study is split into two stages. In the first stage, participants will wear a smartwatch for three weeks and get these special text messages. They'll also attend workshops to share their thoughts and help the researchers make the system even better. In the second stage, some participants will continue with their usual care, while others will get the smartwatch and messaging system, so researchers can compare how they get on. This helps them understand if the new system works well and if patients like using it.

Key takeaways

This study uses smartwatches and texts to help people with paroxysmal AF be more active.
It's checking if this new approach is practical and helpful before a larger trial.
Participation involves wearing a smartwatch and sometimes other monitors, plus giving feedback.
You won't take new medications; the focus is on activity nudges.
Your medical care will not be affected if you choose to withdraw.

Who may be eligible?

To be considered for this study, you need to be 18 years old or older and have been diagnosed with paroxysmal atrial fibrillation. It's important that your AF is currently stable and well-managed by your doctor. You also need to be willing and able to understand what the study involves and agree to take part.

There are certain health conditions that would mean you couldn't join the study. These include if you have other ongoing heart rhythm problems, very high blood pressure, certain heart conditions like recent heart attacks or unstable angina, or severe heart failure. If you've had a stroke in the last six weeks, or have certain other specific heart problems, or an injury that stops you from exercising, you also wouldn't be able to participate. The medical team will check all these details carefully to make sure the study is safe for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with paroxysmal atrial fibrillation?
Is your AF currently stable and well-managed by your doctor?
Do you have any other significant heart problems, like a recent heart attack, stroke, or severe heart failure?
Do you have any injury or condition that stops you from exercising?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in the first phase of the study, you'll wear a smartwatch for three weeks. During this time, you'll receive text messages that give you feedback about your heart rhythm and how active you've been. For the very first part of this phase, you might also be asked to wear an extra heart monitor (like a Holter monitor or chest strap) and another smartwatch for one day, plus a watch that tracks movement for seven days. After the three weeks, you'll attend a workshop to share your experiences and ideas for improving the system.

If you take part in the second phase, you'll be put into one of two groups by chance: one group will continue with their usual medical care, and the other group will get a smartwatch with the special messaging service in addition to their usual care. This phase lasts for about six and a half months. Both groups will complete online questionnaires regularly throughout this period. Also, before the study begins and again at the end, both groups will need to wear a smartwatch and a movement-tracking watch for seven days.

Potential risks and benefits

Taking part in this study may offer some benefits, such as receiving personalised feedback on your heart rhythm and activity levels, which could help you become more active. You would also be contributing to important research that could improve care for others with paroxysmal AF. Potential risks are generally low, mainly related to wearing smartwatches and other monitors, which are non-invasive. You might experience some minor skin irritation from the devices, and there's always the slight chance that the information you receive might cause some worry. However, the researchers have designed the study carefully, and you will always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Liverpool John Moores University
Liverpool, United Kingdom· Recruiting

Common questions

What is paroxysmal atrial fibrillation?

It's a type of irregular heartbeat where the heart sometimes beats too fast or chaotically, but then returns to a normal rhythm on its own.

What is a biofeedback intervention?

It's a technique where you get information (feedback) about your body's functions, like your heart rate, to help you learn to control them or make changes to your behaviour, like being more active.

Will I have to take any new medication?

No, this study does not involve new medications. It focuses on using smartwatches and text messages to encourage physical activity.

What is a smartwatch used for in this study?

The smartwatch will track your heart rhythm and how much you move, and this information will be used to send you personalised feedback via text message.

What if I decide I don't want to continue with the study?

You are free to leave the study at any time, for any reason, and your decision will not affect your medical care.

How to find out more

Luca J Howard

l.j.howard@ljmu.ac.uk + 151 231 2121 Official trial record

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