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YOGA-CF (Yoga Outcomes Get Assessed in Cystic Fibrosis)

Not Applicable
Recruiting
Conditions
Cystic Fibrosis
Interventions
Other: Yoga
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
RECRUITING
Sex
All
Target Recruitment
314
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

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
Arm && Interventions
GroupInterventionDescription
Yoga intervention groupYoga12 week programme of yoga - encouraged to complete 1 live class and one pre-recorded class a week. Participants will continue with usual cystic fibrosis care.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 secondBaseline, 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 TestBaseline, 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.

Trial Locations

Locations (1)

The Royal Brompton Hospital

🇬🇧

London, Greater London, United Kingdom

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