NCT06120465

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

September 19, 2023

Last Update Submit

July 24, 2025

Conditions

Cystic Fibrosis

Keywords

Yoga

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Other Health-related quality of life domains - captured on the Cystic Fibrosis Questionnaire - Revised (CFQ-R)

    Baseline, 12 and 24-weeks

  • One Minute Sit to Stand Test

    Baseline, 12 and 24-weeks

  • Forced Expiratory Volume in 1 second

    Baseline, 12 and 24-weeks

  • Forced vital capacity (FVC)

    Baseline, 12 and 24-weeks

Study Arms (2)

Yoga intervention group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Usual cystic fibrosis care.

Interventions

YogaOTHER

Yoga classes

Yoga intervention group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Brompton Hospital

London, Greater London, SW3 6NP, United Kingdom

Location

Related Publications (1)

  • Stanford GE, Scarborough P, Charman SC, Cameron RA, Wagner AP, Simmonds NJ. Yoga Outcomes Get Assessed in Cystic Fibrosis (YOGA-CF): protocol of a multicentre interventional randomised controlled clinical trial-investigating effects of a 12-week yoga intervention for adults with cystic fibrosis. BMJ Open Respir Res. 2026 Jan 6;13(1):e003405. doi: 10.1136/bmjresp-2025-003405.

    PMID: 41494700DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Yoga

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Nicholas Simmonds

    Royal Brompton Hospital, Guys and St Thomas's Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

November 7, 2023

Study Start

April 22, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)