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

R

Royal Brompton & Harefield NHS Foundation Trust

Status

Enrolling

Conditions

Cystic Fibrosis

Treatments

Other: Yoga

Study type

Interventional

Funder types

Other

Identifiers

NCT06120465
YOGA-CF

Details and patient eligibility

About

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.

Enrollment

314 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

314 participants in 2 patient groups

Yoga intervention group
Active Comparator group
Description:
12 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.
Treatment:
Other: Yoga
Control group
No Intervention group
Description:
Usual cystic fibrosis care.

Trial contacts and locations

1

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Central trial contact

Gemma Stanford; Nicholas Simmonds

Data sourced from clinicaltrials.gov

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