Trial Name:
BREATHE - A controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist by either instructional DVD or by face-to-face sessions in the management of asthma in adults.
Description:
A controlled study of the effectiveness of breathing training exercises taught by DVD or by face to face physiotherapy sessions in the management of asthma in adults.
Objectives:
Primary Objectives:
- To produce a breathing retraining programme for people with asthma (aged 16 to 70 years), incorporating breathing exercise instruction in an audio-visual format (as a DVD) with supporting written material.
- To perform a randomised controlled trial to assess the effect of the programme in comparison with usual care, on asthma-related health status, parameters of symptomatic and physiological asthma control and on asthma-related health resource use in people with impaired health status due to asthma over 12 months following the provision of the intervention.
- To perform a randomised controlled trial to assess the effect of the programme in comparison with that of ‘face-to-face’ physiotherapist-led retraining of similar content.
Secondary Objectives:
- To perform a qualitative process evaluation on 12-15 subjects in each arm of the trial, purposively sampled for diversity.
- To estimate the cost-effectiveness of the breathing retraining interventions delivered by DVD and by face-to-face instruction, using data collected from the trial and from the GP held clinical records.
- To perform an initial ‘internal pilot’ in 2 centres to confirm recruitment targets and protocol viability, and subsequently to extend recruitment to further centres (approximately 20).
Design:
Pragmatic observer blinded 3 arm parallel group randomised controlled trial comparing breathing retraining through a DVD with 'face-to-face' physiotherapy and a 'control' of usual care for adults with asthma and impaired health status.
Status:
Completed
Population:
585 patients with asthma aged 16-70 years recruited across 27 GP surgeries.
Publication:
The BREATHE study: Breathing REtraining for Asthma — Trial of Home Exercises. A protocol summary of a randomised controlled trial
Contact details
All Trial enquiries should be addressed to ctu@soton.ac.uk