N/A
N=64
Breathing Retraining for Asthma Trial of Home Exercises for Teenagers
Adolescent Behavior · Asthma
Bottom Line
View on ClinicalTrials.gov: NCT05006703 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Asthma-specific Quality of Life — 65.4; 65.1; 66.7; 67.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breathe for Teens (Breathe4T) (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- University of Southampton
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma-specific Quality of Life |
65.4; 65.1; 66.7; 67.4 | — |
| PRIMARY Asthma Control |
17.2; 17.4; 16.9; 17.8 | — |
| PRIMARY Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) |
9; 11; 23; 21; 5; 6 | — |
| SECONDARY Attendance at Emergency Department for an Exacerbation of Asthma |
5; 4; 27; 28; 0; 2 | — |
| SECONDARY Hospital Admission for an Exacerbation of Asthma |
14; 17; 18; 15; 0; 2 | — |
| SECONDARY Paediatric Quality of Life |
4.5; 5.1; 5.7; 4.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Young people aged 12-17 years
- Physician diagnosed asthma
- Impaired quality of life (<85)
- Under the care of a general practitioner, community or hospital practitioner for their asthma
Exclusion Criteria
- Co-existent respiratory conditions such as bronchiectasis
- Already using breathing techniques
- Already enrolled in another interventional study
- Lack of informed consent
- Learning difficulties
- Previously involved with Stages 1 and 2 of the study
Data sourced from ClinicalTrials.gov (NCT05006703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.