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N/A N=64 Randomized Single-blind Supportive Care

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

Adolescent Behavior · Asthma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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