YOGA-CF (Yoga Outcomes Get Assessed in Cystic Fibrosis)
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT06120465
- Lead Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Brief Summary
The goal of this clinical trial is to investigate the effects of yoga participation for adults with cystic fibrosis.
The main question it aims to answer is: does participation in yoga affect health-related quality of life for adults with cystic fibrosis?
Researchers will compare a group completing a 12-week yoga programme alongside usual cystic fibrosis care, to a group completing usual care alone to see if the addition of yoga effects health-related quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 314
Diagnosis of CF (confirmed by standard criteria; (Farrell et al. 2017))
Sixteen years of age or over
Home internet access
Ability to complete questionnaires in English
Stable CF disease as judged by the investigator, a senior CF clinician
Inability to consent for treatment or measurement
Current participation in another interventional study of a medicinal product
Current haemoptysis (greater than streaking in the sputum)
Known pregnancy at time of recruitment
Forced expiratory volume in 1 second (FEV1) below 30% predicted at baseline
Use of ambulatory oxygen therapy, long-term oxygen therapy (LTOT) or non-invasive ventilation
Current regular participation in yoga practice
Current neurological or musculoskeletal injury which would prevent completion of yoga
Diagnosis of osteoporosis (bone density Z score <-2.5) or history of spontaneous spinal fractures
Uncontrolled gastroesophageal reflux
Acute pulmonary exacerbation within 28 days of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Respiratory Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised. Baseline, 12 and 24-weeks Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain.Scores range from 0 to 100, with higher scores indicating better health.
- Secondary Outcome Measures
Name Time Method Other Health-related quality of life domains - captured on the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Baseline, 12 and 24-weeks Cystic Fibrosis Questionnaire - Revised (CFQ-R) other eleven domains. Scores range from 0 to 100, with higher scores indicating better health.
Forced Expiratory Volume in 1 second Baseline, 12 and 24-weeks Forced expiratory volume in 1 second (FEV1) obtained through spirometry. Measured in litres and percentage predicted (using Global Lung Index equations)
Forced vital capacity (FVC) Baseline, 12 and 24-weeks Forced vital capacity obtained through spirometry. Measured in litres and percentage predicted (using Global Lung Index equations)
One Minute Sit to Stand Test Baseline, 12 and 24-weeks Participant stands up and sits down from a chair for one minute and the number of completed sit-to-stands is recorded.
Related Research Topics
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Trial Locations
- Locations (1)
The Royal Brompton Hospital
🇬🇧London, Greater London, United Kingdom
The Royal Brompton Hospital🇬🇧London, Greater London, United KingdomGemma Stanford, BSc (Hons) PhysiotherapyContact020 7352 8121g.stanford@rbht.nhs.uk