Cystic Fibrosis
Conditions
Keywords
Yoga
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.
Interventions
OTHERYoga
Yoga classes
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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) |
Countries
United Kingdom
Outcome results
None listed