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

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06120465
• Collaborator: (none)
• Enrollment: 314
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.3
• Patients Per Site Per Month: 16.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: Yoga	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 314 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Yoga Outcomes Get Assessed in Cystic Fibrosis
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jul 10, 2025
• Anticipated Study Completion Date: Jul 10, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised. [Baseline, 12 and 24-weeks]

   CFQ-R respiratory domain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Royal Brompton Hospital	London	Greater London	United Kingdom	SW3 6NP

Sponsors and Collaborators

• Royal Brompton & Harefield NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT06120465
• Other Study ID Numbers: YOGA-CF
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Royal Brompton & Harefield NHS Foundation Trust: Yoga
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Nov 7, 2023