RecruitingInterventional

Supported inspiratory muscle training for people with chronic obstructive pulmonary disease who have declined pulmonary rehabilitation

This study aims to find a new way to help people with a lung condition called COPD (Chronic Obstructive Pulmonary Disease) who haven't been able to join regular breathing exercise programs called Pulmonary Rehabilitation. We're testing a method called 'Supported Inspiratory Muscle Training' (SIMT). This involves using a handheld device to strengthen your breathing muscles, with support to keep you motivated. We want to see if SIMT can improve symptoms, make it easier to join Pulmonary Rehabilitation later, and potentially save the NHS money. This is a small, initial study to check if SIMT is acceptable to patients and if our study methods are sound for a larger trial. Participants will be aged 35 or over with COPD, and will be randomly assigned to either receive the supported training or a 'sham' (inactive) version, along with breathing exercises. We'll follow them for 9 months, checking their breathing, activity, and asking them to complete questionnaires.

At a glance

Status

Recruiting

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

05 Jan 2026

Estimated completion

30 Sep 2027

Chronic obstructive pulmonary disease

What is this study about?

If you have a lung condition called COPD (that's Chronic Obstructive Pulmonary Disease), you might know about a special exercise programme called Pulmonary Rehabilitation. It's often recommended because it can really help with your breathing and overall well-being. However, we know that for different reasons, many people with COPD aren't able to take part in these programmes. This can put them at a higher risk of needing to go to the hospital.

This study is looking at a different approach called Supported Inspiratory Muscle Training (SIMT). "Inspiratory" means breathing in, so this training focuses on strengthening the muscles you use to breathe in. You do this by breathing through a small handheld device against a gentle resistance. The 'supported' part means you'll have help and encouragement to keep you motivated and on track with your training. We think SIMT could be a good option to help improve symptoms, and perhaps even make it easier for people to do Pulmonary Rehabilitation later on.

Right now, this is a 'feasibility study'. This means it's a smaller, early-stage study designed to answer some important questions before we potentially run a much larger one. We want to make sure that SIMT is something people with COPD find acceptable and helpful, and we're also checking if our study plan and methods work well. The information gathered from this study will help us design a bigger, more conclusive research project in the future to see if SIMT truly is a worthwhile and effective treatment.

Key takeaways

This study tests a new breathing exercise programme (SIMT) for people with COPD.
It's for those who haven't been able to do traditional Pulmonary Rehabilitation.
Participants will use a hand-held device to strengthen breathing muscles, with support.
The study aims to see if SIMT helps symptoms and prepares people for future rehabilitation.
It's a small initial study to check if the programme and study methods work well for a bigger trial.
All training and assessments are done in your own home.

Who may be eligible?

To be able to take part in this study, you need to be at least 35 years old and have a stable diagnosis of COPD. This means you haven't recently had a flare-up that needed antibiotics or steroids in the last four weeks. Your breathlessness should be at a level where you find yourself walking slower than others your age, or you need to stop to catch your breath when walking at your own pace.

Crucially, you should also have previously been offered Pulmonary Rehabilitation but decided not to take part, or you started but couldn't continue after the first couple of sessions. This study is specifically for people who haven't engaged with Pulmonary Rehabilitation.

There are also some reasons why you wouldn't be able to join. For example, if you've had a collapsed lung (pneumothorax) before, or if you have certain heart conditions like unstable angina or abnormal heart rhythms. Other reasons include having asthma, a perforated eardrum, being pregnant, or having had a stroke or heart attack within the last two months. You also can't take part if you've done more than two sessions of Pulmonary Rehabilitation in the past year.

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.

I am aged 35 or older.
I have been diagnosed with stable COPD.
I get breathless easily when walking.
I was offered Pulmonary Rehabilitation but didn't take part, or couldn't continue with it.
I haven't had a lung flare-up needing antibiotics/steroids in the last 4 weeks.
I don't have certain heart conditions or other serious health issues listed.

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be part of it for 9 months. We're looking for about 34 people. You'll be randomly put into one of two groups: either a group receiving the supported breathing muscle training, or a group receiving a 'sham' (inactive) version of the training (this is to help us compare the effects). Both groups will also learn breathing exercises.

The training involves breathing deeply and quickly through a handheld device for a few minutes, specifically 30 breaths, twice a day, five days a week. For the first two months, you'll have weekly support visits at home to help you set goals and get feedback. After that, for the remaining seven months, you'll continue training three times a week without the weekly support visits. All assessments and training will be done in your own home to make it easier for you.

At the start of the study, and then again after 2 months and 9 months, you'll have a few assessments. These include a breathing test, wearing a small activity monitor for five days, and filling out six short questionnaires. Some staff involved in the study and 10-15 participants from the training group will also be asked for interviews during the study to get their feedback.

Potential risks and benefits

There's a chance you might notice some improvement in your breathing symptoms by taking part, although we can't promise specific benefits. Your involvement will definitely help researchers understand more about COPD and how to support people who haven't taken part in Pulmonary Rehabilitation, which could benefit many others in the future and potentially save money for our NHS. One 'risk' is that if you're in the control group, the training device won't be set to an effective level, which might be disappointing if you hoped for direct improvement from the device. To help with this, both groups will learn breathing exercises, and everyone will be offered an active breathing muscle trainer at the end of the study. You might experience some mild muscle soreness, similar to what you feel after exercise, especially when you first start training or after assessments. This isn't expected to be severe and should go away within a day. We minimise this by starting training very gently. While the training involves regular sessions, public feedback has suggested it's manageable, especially as visits and training are mostly done at home. You are always free to leave the study at any time.

Locations (1)

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

Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, England

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties.

What is 'Pulmonary Rehabilitation'?

It's a special exercise and education programme designed to help people with lung conditions manage their symptoms and improve their quality of life.

What is 'Inspiratory Muscle Training'?

It's a way to strengthen the muscles you use to breathe in, often by breathing through a device that creates some resistance.

Will I know if I'm getting the 'real' training or the 'sham' training?

No, you won't know which group you are in. This is important for the study to fairly compare the effects of the active training versus no active training.

How long will I be involved in the study?

You will be involved for a total of 9 months.

How to find out more

Sarah Wilkinson

sarah.wilkinson71@nhs.net +44 (0)114 271 1658 ext 11658 Official trial record

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