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

Yoga Outcomes Get Assessed in Cystic Fibrosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Yoga

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SW3 6NP
      • The Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yoga intervention group; 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.	Other: Yoga; Yoga classes
No Intervention: Control group; Usual cystic fibrosis care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised.	Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain.Scores range from 0 to 100, with higher scores indicating better health.	Baseline, 12 and 24-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Health-related quality of life domains - captured on the Cystic Fibrosis Questionnaire - Revised (CFQ-R)	Cystic Fibrosis Questionnaire - Revised (CFQ-R) other eleven domains. Scores range from 0 to 100, with higher scores indicating better health.	Baseline, 12 and 24-weeks
One Minute Sit to Stand Test	Participant stands up and sits down from a chair for one minute and the number of completed sit-to-stands is recorded.	Baseline, 12 and 24-weeks
Forced Expiratory Volume in 1 second	Forced expiratory volume in 1 second (FEV1) obtained through spirometry. Measured in litres and percentage predicted (using Global Lung Index equations)	Baseline, 12 and 24-weeks
Forced vital capacity (FVC)	Forced vital capacity obtained through spirometry. Measured in litres and percentage predicted (using Global Lung Index equations)	Baseline, 12 and 24-weeks

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Nicholas Simmonds, Royal Brompton Hospital, Guys and St Thomas's Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Yoga
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: YOGA-CF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No