Active not recruitingNAINTERVENTIONAL

Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol

This study aims to understand what helps or hinders people with Cystic Fibrosis (CF) in being physically active every day. Physical activity is very important for people with CF, offering many health benefits. However, we don't fully understand why some people with CF are less active than recommended. To find out more, participants will wear a small, lightweight device, called an accelerometer, for a week. This device quietly measures their daily movements. They will also complete a questionnaire designed to gather information about their feelings, their home life, and their local environment. By looking at all this information together, researchers hope to discover the most important factors influencing activity levels, which could help create better ways to encourage physical activity for people with CF in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Limoges

Enrolment target

Start

19 Sep 2022

Estimated completion

20 Dec 2024

Cystic Fibrosis

What is this study about?

Being active is really important for everyone, and it's especially helpful for people living with conditions like Cystic Fibrosis (CF). Regular physical activity can lead to a longer, healthier life. However, doctors have noticed that many people with CF aren't as active as health guidelines suggest, but we don't fully understand why this is. Is it down to how they feel, what their home life is like, or maybe things in their local area? This study hopes to answer these questions.

The main goal of this research is to figure out what encourages or prevents people with CF from being physically active each day. Researchers want to understand all the different factors that play a part, from personal feelings and physical abilities to social situations and their surroundings. Until now, most studies have looked at these things separately, or only in children. This new study aims to get a complete picture by looking at everything together.

By getting a better understanding of what influences daily activity, this research could open the door to creating better support programmes. These programmes could then help people with CF to be more active, which in turn could improve their health and quality of life. It's all about finding the best ways to help people with CF enjoy the benefits of being active.

Key takeaways

Aims to understand what helps or stops people with CF from being active.
No new medicines or extra hospital visits are needed.
Involves wearing a small activity monitor for one week.
Also includes filling out a questionnaire about daily life.
Helps researchers create better ways to encourage activity for people with CF.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

To be part of this study, you would need to have a confirmed diagnosis of Cystic Fibrosis, meaning it's been identified through genetic tests or a sweat test. You should also be regularly seen at a CF clinic. Participants need to be over 6 years old and in a stable condition, meaning you're not currently having a flare-up of your CF symptoms or receiving antibiotic treatment for an infection.

There are a few reasons why someone might not be able to join. For example, if you've had a transplant or are waiting for one, this study wouldn't be suitable. You also need to be able to complete the questionnaire and evaluations on your own. If you're involved in another active research study that involves a treatment or intervention, you wouldn't be able to take part in this one. Lastly, if you prefer not to participate, or if you're under legal protection, you wouldn't be included.

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.

Do you have a confirmed diagnosis of Cystic Fibrosis?
Are you regularly seen at a CF clinic?
Are you 6 years old or older?
Are you currently in a stable condition, without a flare-up or antibiotic treatment?
Have you not had an organ transplant or are you not waiting for one?
Are you able to fill in a questionnaire and complete simple evaluations?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it's quite straightforward. You won't need to take any new medicines or have extra hospital visits. The main part of your involvement will be wearing a small, lightweight device called an accelerometer for one week. This device is worn continuously and simply measures your daily physical activity without you needing to do anything special.

During that same week, you will also receive a questionnaire to fill out. This questionnaire asks about different aspects of your life, including your feelings, your social life, and your surroundings. It's designed to understand what might help or hinder your activity levels. Once you've worn the device for a week and completed the questionnaire, your direct involvement in the study will be finished. The total duration of your active participation will therefore be one week.

Potential risks and benefits

Participating in this study involves minimal risks. Wearing the small activity device is generally very safe and comfortable, and it won't affect your daily routines. Filling out the questionnaire is also low-risk, though some questions might make you think about your habits. You are always free to skip any question you don't wish to answer. While there's no direct medical benefit to you personally, the information gathered will be extremely valuable for understanding how to help other people with CF become more active in the future. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique
Verified postcode
Bordeaux, France
CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte
Verified postcode
Bordeaux, France
CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte
Verified postcode
Limoges, France
CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique
Verified postcode
Limoges, France
CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique
Verified postcode
Toulouse, France
CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte
Verified postcode
Toulouse, France

Common questions

What is an accelerometer?

It's a small, wearable device that measures how much you move throughout the day, like a fancy step counter.

How long do I need to wear the device?

You'll wear the device for a whole week, or 7 days.

Do I have to do any special exercises?

No, you just continue with your usual daily activities. The study simply observes what you normally do.

What kind of questions are on the questionnaire?

The questionnaire asks about your feelings, your social life, and things in your environment that might affect your activity.

Will my information be kept private?

Yes, all your personal information and study data will be kept strictly confidential and anonymous.