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NCT06120465 Clinical Trial

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

Cystic Fibrosis Clinical Trial

— YOGA-CF  

Official title:
Yoga Outcomes Get Assessed in Cystic Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06120465
Other study ID # YOGA-CF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date July 10, 2025

Study information
Verified date November 2023
Source Royal Brompton & Harefield NHS Foundation Trust
Contact Gemma Stanford
Phone 0207 3528121
Email g.stanford@rbht.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 314
Est. completion date July 10, 2025
Est. primary completion date July 10, 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Yoga
Yoga classes

Locations
Country Name City State
United Kingdom The Royal Brompton Hospital London Greater London

Sponsors (1)
Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised. CFQ-R respiratory domain Baseline, 12 and 24-weeks
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