Fitness, Body Composition, Physical Activity and Sleep Patterns in People With Cystic Fibrosis on… (NCT05857709) | Clinical Trial Compass
UnknownNot Applicable
Fitness, Body Composition, Physical Activity and Sleep Patterns in People With Cystic Fibrosis on Modulator Therapy.
United Kingdom100 participantsStarted 2023-01-10
Plain-language summary
Cystic fibrosis (CF) is the most common inherited condition in the United Kingdom, affecting approximately 10,837 people. It is well recognised that regular exercise is clinically important for people with CF. Exercise function measured by the maximal oxygen consumption during a cardiopulmonary exercise test is often reduced in people with CF and this has been attributed to multiple factors including, altered heart and blood vessel function, muscle function, reduced physical activity levels and poorer sleep quality.
New medicine (modulators) have become available for many people with CF. Modulators appear able to reduce sweat chloride concentrations, improve lung function and reduce the frequency of pulmonary exacerbations in people with CF. Little evidence exists to show how they may have changed the fitness and underlying mechanisms responsible for this in people with CF.
This study aims to:
1. determine the exercise function
2. determine the blood vessel function
3. determine body composition
4. determine physical activity and sleep levels in people with CF on modulator therapy compared to a healthy controls group.
Who can participate
Age range10 Years
SexALL
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Inclusion criteria for participants with cystic fibrosis:
* Stable on the modulator therapy, Kaftrio®
* Males and females ≥ 10 years of age
* CF diagnosis based on clinical features, supported by a history of an abnormal sweat test (sweat chloride \> 60 mmol·L-1 \> 100 mg sweat), where possible, diagnostic genotyping would also be desired
* Can clearly state that they are not pregnant
* No contraindications to performing exercise
* Can understand and cooperate with the study protocol
* No increase in symptoms or weight loss in the preceding 2 weeks
Inclusion criteria for healthy control participants:
* Healthy males and females who are age- and sex-matched to the enrolled individuals with CF
* Can clearly state that they are not pregnant
* No clinical diagnosis of a chronic disease
* Can understand and cooperate with the study protocol
* No contraindications to performing exhaustive exercise
Exclusion criteria for participants with cystic fibrosis:
* Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders and cardiovascular disease.
* Unstable co-morbid asthma (daily pulmonary function variability of \>20%)
* Is pregnant during the initial screening process
* Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
* Not of a suitable age for testing
* Is a smoker or inhales any other substances
* Are taking vasoactive medications
Exclusion criteria for healthy control participants:
* A…