RecruitingOBSERVATIONAL

Diaphragmatic Function as a Biomarker

This study is about understanding why people with lung conditions like asthma, COPD, fibrosis, or pulmonary hypertension often feel breathless. Researchers believe that problems with the diaphragm, a key breathing muscle, might play a big role. We will measure how well your breathing muscles work, your lung function, and how easily you can exercise. By following people over time, we hope to find out if diaphragm weakness can predict how your condition might progress, for example, if it means you're more likely to have a flare-up or need hospital care. This information could help doctors better manage these conditions in the future.

At a glance

Status

Recruiting

Sponsor

RWTH Aachen University

Enrolment target

800

Start

01 Jul 2023

Estimated completion

30 Dec 2026

Dyspnea; Asthmatic COPD Fibrosis Pulmonary Hypertension Asthma Dyspnea

What is this study about?

Many people with lung conditions such as asthma, COPD, pulmonary fibrosis, or pulmonary hypertension often experience breathlessness. While we know this feeling is very common, doctors don't fully understand all the reasons behind it or how it affects people long-term. This study wants to investigate a specific area: how well your breathing muscles, especially a main one called the diaphragm, are working.

The research aims to get a complete picture of your breathing muscles' strength and function. By doing this, the researchers hope to see if there's a link between how well your diaphragm works and how breathless you feel, as well as your ability to do daily activities. They will also look at whether problems with your diaphragm could help predict future issues, such as needing to go to the hospital or having a severe flare-up of your condition.

Ultimately, the goal is to learn more about the role of the diaphragm in these lung conditions. This knowledge could help doctors better understand why people feel breathless and find new ways to help manage these conditions, potentially leading to better care for patients in the future.

Key takeaways

This study explores why people with lung conditions feel breathless.
It focuses on the role of the diaphragm, a key breathing muscle.
Participation involves an initial day of tests and follow-up phone calls.
A small number of participants will have in-person follow-up visits.
The study aims to improve understanding and future care for lung conditions.
Your involvement will last for 18 months.

Who may be eligible?

To join this study, you must be at least 18 years old and have one of the following lung conditions: asthma, COPD, pulmonary fibrosis, or pulmonary hypertension. You should feel well enough to understand what's involved and follow the study instructions.

There are certain reasons why you might not be able to join. For example, if your body mass index (BMI) is over 35, or if you have certain other health issues like a slipped disc or epilepsy. If you've been in hospital recently or have conditions that might affect the study results, you might also be excluded.

Also, if you're unable or unwilling to take an active part in the study, or if you have specific personal circumstances like being in a dependent relationship with one of the doctors involved, you won't be able to participate.

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 18 years old or older.
I have asthma, COPD, pulmonary fibrosis, or pulmonary hypertension.
I am able to understand and follow study instructions.
I do not have a BMI over 35.
I have not been in hospital in the last 4 weeks.
I am willing and able to take part actively.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first come to the lab for a full day. During this visit, we'll measure your breathing muscle strength, how well your lungs are working, and your exercise ability. This will involve different tests, including ultrasounds of your breathing muscles, walking tests, and questionnaires about your symptoms.

After this initial visit, most participants will be contacted by phone for follow-up calls at 3, 6, 12, and 18 months to check on your health and any changes. For a small group of up to 50 people, especially those who have recently started a new specific medication for their condition, you might also be asked to come back to the lab for repeat measurements in person, in addition to the phone calls. The total duration of your involvement will be 18 months.

Potential risks and benefits

Taking part in this study could help us learn more about lung conditions, which might lead to better care for patients in the future. While there are no direct medical benefits for you, your information will be very valuable. The tests involved are generally safe, but some might cause mild discomfort, like breathing into a device or walking. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

RWTH Aachen University Hospital
Verified postcode
Aachen, Germany· Recruiting

Common questions

What is the diaphragm?

The diaphragm is a large, dome-shaped muscle located at the base of your chest. It's the main muscle you use for breathing.

What does 'dyspnea' mean?

Dyspnea is the medical term for feeling breathless or short of breath, often described as a tight feeling in your chest or a feeling of not getting enough air.

Will I have to take any new medications during the study?

No, this study is about understanding your condition and breathing, not about testing new medications. Any medications you are taking will be your usual treatment.

How long will the initial visit take?

Your first visit to the lab will take a full day to complete all the tests and measurements.

What kind of walking test will I do?

You might do a 6-minute walking test, where you walk for six minutes to see how far you can go, or a sit-to-stand test to see how many times you can stand up from a chair in 60 seconds.

How to find out more

Jens Spiesshoefer, MD

jspiesshoefer@ukaachen.de 0049 2418037036 Official trial record

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