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Trikafta Exercise Study in Cystic Fibrosis

This study is investigating how a new medicine for cystic fibrosis (CF), called Trikafta, might help people with the condition. Many people with CF experience shortness of breath during exercise, which can be distressing and affect their quality of life. While Trikafta is known to improve lung health, it's not yet clear how much it helps with exercise performance and feeling breathless during physical activity. Exercise ability is a really important indicator of overall health and can even predict how long someone with CF might live. Therefore, this research aims to understand if Trikafta can improve these areas, offering new insights into how this treatment might benefit people further.

At a glance

Status
Recruiting
Sponsor
University of British Columbia
Enrolment target
20
Start
10 Nov 2021
Estimated completion
01 Jan 2027

What is this study about?

Cystic fibrosis (CF) is a serious condition that affects many parts of the body, especially the lungs. As treatments have improved, people with CF are living longer, but many still struggle with feeling breathless, especially when they exercise. This breathlessness can make daily life difficult and impact their overall well-being. A new treatment called Trikafta has shown promise in improving lung health for people with CF.

While Trikafta helps the lungs work better, researchers want to find out if these improvements also lead to a better ability to exercise and less shortness of breath during physical activity. Being able to exercise well is a significant sign of good health in people with CF, and understanding how Trikafta affects this is very important. This study will look closely at how Trikafta changes the way people breathe and perform during exercise.

The main goal is to understand what causes shortness of breath in people with CF and how Trikafta might change these factors. They hope to learn if Trikafta can make it easier for people with CF to exercise and feel less breathless, ultimately aiming to improve their quality of life.

Key takeaways

  • This study focuses on how Trikafta affects shortness of breath and exercise in CF.
  • Exercise ability is a key marker of health in cystic fibrosis.
  • Researchers want to understand how Trikafta improves exercise performance.
  • Participation involves exercise tests and health assessments.
  • The study aims to provide new insights into Trikafta's benefits for people with CF.

Who may be eligible?

To take part in this study, you need to be at least 19 years old and have been diagnosed with cystic fibrosis. It's important that your doctor has decided you will start taking Trikafta within a month of joining the study. You'll also need to be generally stable in your health, as judged by your doctor, and have a lung function (FEV1) that's less than 90% of what's expected for someone your age and size. Your body weight should also be within a certain range (BMI between 16 and 30), and you shouldn't be a current smoker, or if you have smoked in the past, it should be less than 20 'pack-years'. You'll also need to be able to understand and read English, and have had at least two doses of a COVID-19 vaccine.

There are also some reasons why you might not be able to join. For example, if you have another illness that significantly causes shortness of breath or limits your exercise, or if you have certain types of lung infections. You also can't participate if you need extra oxygen, have very low oxygen levels during exercise, or have had a collapsed lung in the last four weeks. If you've had an organ transplant, you also won't be able to take part.

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 19 years old or older?
  2. Do you have a confirmed diagnosis of cystic fibrosis?
  3. Is your doctor planning for you to start Trikafta within the next month?
  4. Is your general health stable according to your doctor?
  5. Can you read and understand English?
  6. Have you had at least two doses of the COVID-19 vaccine?
Answer every question to see your result.

What does participation involve?

The study involves several visits where you will undergo different tests to measure your breathing and how well you can exercise. This will include tests before you start taking Trikafta and again after you have been on the medication for some time. You will continue to take Trikafta as prescribed by your doctor throughout the study. The researchers will be looking at things like your shortness of breath, how far and how easily you can exercise, and your body composition (like muscle and fat). They will also ask you to fill out questionnaires about how you feel. The total duration of your participation in the study will be determined by the researchers, but it will involve follow-up assessments after you start taking Trikafta.

Potential risks and benefits

Participating in this study could offer insights into how Trikafta specifically helps with exercise and shortness of breath, which might lead to improved treatments for others in the future. As with any exercise testing, there are minor risks like feeling tired or breathless, but these tests will be supervised by medical professionals. Taking the study medication, Trikafta, comes with its own known side effects, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • UBC Centre for Heart Lung Innovation, St. Paul's Hospital
    Verified postcode
    Vancouver, Canada· Recruiting

Common questions

What is Trikafta?

Trikafta is a medicine for people with cystic fibrosis that helps improve how the body's cells work to clear mucus, leading to better lung health.

Why is exercise important in CF?

Being able to exercise is a key sign of overall health and can help a person with CF live longer and have a better quality of life.

Will I have to do difficult exercises?

You will do exercise tests to see how your body responds, but these will be monitored by health professionals to ensure your safety.

Will this study change my Trikafta treatment?

No, you will continue to take Trikafta as prescribed by your own doctor as part of your regular treatment.

What if I feel unwell during the study?

Your safety is a priority. Medical staff will be present during tests, and you can stop participating at any point if you feel unwell or have concerns.

How to find out more

Satvir S Dhillon, MSc

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 "Trikafta Exercise Study in Cystic Fibrosis…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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