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Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases

This study aims to make exercise tests for people with lung conditions like COPD and Interstitial Lung Disease (ILD) easier and more accessible. Researchers are looking at a test called the 6-minute stepper test. They want to see if it’s a good way to measure fitness compared to other tests, and if it can be done safely and accurately at home, even with help from a therapist through video calls. This could mean more people can check their fitness without needing to travel to a clinic. Participants will try different exercise tests and share their thoughts on the stepper test.

At a glance

Status
Recruiting
Sponsor
Laval University
Enrolment target
82
Start
02 Feb 2024
Estimated completion
01 Jan 2026

What is this study about?

Imagine you have a long-term lung condition like COPD or Interstitial Lung Disease (ILD). Keeping track of your fitness and how well your lungs are working is really important. Doctors often use exercise tests to do this. This study is looking at a new way to measure how well you can move and breathe, using something called the 6-minute stepper test.

The main idea is to find out if this stepper test is as good and accurate as other common tests, like the 6-minute walk test or a cycling test you might do at the hospital. They also want to understand if this test can be done safely and reliably at home. This is important because it could make it much easier for people to monitor their health without needing to travel to a clinic. Imagine having a therapist guide you through the test using a video call – that's one of the things they're exploring.

Ultimately, if this study shows the 6-minute stepper test is accurate, safe, and works well at home, it could become a valuable tool for both patients and healthcare providers. It could help doctors better understand how your lung condition is affecting you and help you keep track of your own fitness in a convenient way.

Key takeaways

  • This study explores a new step test for people with lung conditions.
  • It aims to see if the test is accurate and safe when done at home.
  • The step test is compared to other common fitness tests.
  • Participation involves doing a few different exercise tests.
  • The goal is to make fitness monitoring more accessible for patients.

Who may be eligible?

To join this study, you need to be at least 40 years old. You must have a diagnosis of moderate to very severe COPD or a type of Interstitial Lung Disease (ILD) that you've had for at least six months. It's important that your health has been stable for at least four weeks before joining, meaning no big changes in your condition.

There are also some reasons why you might not be able to join. For example, if your ILD is linked to certain other conditions like sarcoidosis, or if you have a serious heart problem that isn't stable. You also won't be able to take part if you have other physical issues that would make exercise testing difficult or unsafe, or if your weight is more than the equipment can handle (around 130 kg or 20 stone).

Finally, if you've recently completed pulmonary rehabilitation (within the last year), or are already in another study where your medication is changing, you won't be eligible. If you're in one specific part of the study, using oxygen therapy might also affect your eligibility.

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.

  1. Are you 40 years old or older?
  2. Do you have COPD or Interstitial Lung Disease (ILD) for at least six months?
  3. Has your health been stable for the last four weeks?
  4. Are you able to do some exercise without serious limitations?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to do a few different exercise tests. You'll do the 6-minute stepper test several times over different days. You'll also do a 6-minute walk test and a cycling test that measures your heart and lung function, each on a separate day. Afterward, you'll have a chat with the researchers to share your thoughts and experiences about the 6-minute stepper test. The study does not mention any changes to your regular medication, and the total duration is not specified but will involve several visits for the tests.

Potential risks and benefits

Taking part in this study might help researchers understand better ways to test fitness for people with lung conditions. This could lead to more convenient testing options in the future. As with any exercise, there's a small risk of feeling tired or breathless. The research team will be there to make sure you are safe during the tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
    Verified postcode
    Québec, Canada· Recruiting
  • Groupement des Hôpitaux de l'Institut Catholique de Lille
    Verified postcode
    Lille, France· Recruiting
  • FormAction Santé
    Verified postcode
    Pérenchies, France· Not yet recruiting

Common questions

What is the 6-minute stepper test?

It's an exercise test where you step up and down for six minutes to see how well your lungs and heart work.

What's the difference between direct and remote monitoring?

Direct means a therapist is with you in person. Remote means they guide you using video calls, like Zoom.

Why is this study important?

It could help find easier and safer ways for people with lung conditions to check their fitness regularly, possibly even from home.

Will I have to change my medication?

No, this study does not require you to change any of your current medications.

How long will I need to participate?

The study involves several separate days for testing, but the total duration isn't specified. It will involve a few visits.

How to find out more

Alec Bass, PT, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Assessing Functional Capacity in Directly and Remotely Monit…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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