NCT05006703

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers (Breathe4T); Re-purposing, Refining and Feasibility - Stage 3

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. Research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. Although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. The investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma. The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the Breathe 4 Teens (BREATHE4T) project. A self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform. The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. Asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website. The online nature of this study allows recruitment from across the United Kingdom. Recruitment methods would include primary care, hospital clinics, social media and posters. AsthmaUK will also provide publicity to assist recruitment.

Detailed description

The trial will aim to assess the acceptability, uptake and success in collecting follow up data and variance in asthma-related outcome measures. A parallel group design will be used with participants being randomised to intervention or normal management. The intervention will be a self-guided, breathing retraining digital intervention, delivered via a mobile-friendly, online platform. The intervention will continue to be used for 6 months after which both groups will be reassessed. The usual management control group will then have access to the intervention (delayed access).

Conditions

• Adolescent Behavior
• Asthma

Interventions

Type	Name	Description
BEHAVIORAL	Breathe for Teens (Breathe4T)	A digital, self-management intervention for adolescents to control their asthma using breathing retraining. The mobile-friendly website provides information about asthma, how it affects the lungs, and how breathing patterns can be dysfunctional. Information is presented using short (30sec-2min) video clips featuring physiotherapists, researchers and adolescent role models. Users are given tips about their practice, including choosing a suitable time and place and building up gradually. Users can plan and log their practice and record their confidence in using the breathing techniques. There are 8 sessions including peer-led videos demonstrating breathing exercises with voiceovers and step-by-step instructions. All features and sessions can be accessed via a main dashboard where users can tailor the intervention to allow parental involvement, reminders and a preferred format for notifications (email/text). Other features include frequently asked questions (FAQs) and a progress chart.

Timeline

• Start date: 2021-06-22
• Primary completion: 2022-06-30
• Completion: 2022-09-30
• First posted: 2021-08-16
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United Kingdom