Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark

Karen Hjerrild Andreasson, Søren Thorgaard Skou, Charlotte Suppli Ulrik, Hanne Madsen, Kirsten Sidenius, Jannie Søndergaard Jacobsen, Karin Dahl Assing, Kirsten Brændholt Rasmussen, Celeste Porsbjerg, Mike Thomas, Uffe Bodtger, Karen Hjerrild Andreasson, Søren Thorgaard Skou, Charlotte Suppli Ulrik, Hanne Madsen, Kirsten Sidenius, Jannie Søndergaard Jacobsen, Karin Dahl Assing, Kirsten Brændholt Rasmussen, Celeste Porsbjerg, Mike Thomas, Uffe Bodtger

Abstract

Introduction and aim: Uncontrolled asthma is a global health challenge with substantial impact on quality of life (QoL) and overall healthcare costs. Unrecognised and/or unmanaged comorbidities often contribute to presence of uncontrolled asthma. Abnormalities in breathing pattern are termed dysfunctional breathing and are not only common in asthma but also lead to asthma-like symptoms and reduced QoL, and, in keeping with this, improvement with breathing normalisation. Evidence-based guidelines recommend breathing retraining interventions as an adjuvant treatment in uncontrolled asthma. Physiotherapy-based breathing pattern modification interventions incorporating relaxation have been shown to improve asthma-related QoL in primary care patients with impaired asthma control. Despite anecdotal reports, effectiveness of breathing retraining in patients referred to secondary care with incomplete asthma control has not been formally assessed in a randomised controlled trial (RCT). We aim to investigate the effect of breathing exercises on asthma-related QoL in patients with incomplete asthma control despite specialist care.

Methods and analysis: This two-armed assessor-blinded multicentre RCT will investigate the effect of physiotherapist-delivered breathing retraining on asthma QoL questionnaire (MiniAQLQ) in addition to usual specialist care, recruiting from seven outpatient departments and one specialised clinic representing all regions of Denmark during 2017-2019. We will include 190 consenting adults with incomplete asthma control, defined as Asthma Control Questionnaire 6-item score ≥0.8. Participants will randomly be allocated to either breathing exercise programme in addition to usual care (BrEX +UC) or UC alone. BrEX compiles three physiotherapy sessions and encouragement to perform home exercise daily. Both groups continue usual secondary care management. Primary outcome is between-group difference in MiniAQLQ at 6 months. Secondary outcomes include patient-reported outcome measures, spirometry and accelerometer.

Ethics and dissemination: Ethics Committee, Region Zealand (SJ-552) and Danish Data Protection Agency (REG-55-2016) approved the trial. Results will be reported in peer-reviewed scientific journals.

Trial registration number: NCT03127059; Pre-results.

Keywords: asthma; asthma control; asthma quality of life questionnaire; breathing exercises; dysfunctional breathing; physiotherapist-delivered breathing retraining.

Conflict of interest statement

Competing interests: STS is an associate editor of the Journal of Orthopaedic & Sports Physical Therapy, has received grants from The Lundbeck Foundation, personal fees from Munksgaard, all of which are outside the submitted work. He is co-founder of GLA:D®, a not-for profit initiative hosted at University of Southern Denmark aimed at implementing clinical guidelines for osteoarthritis in clinical practice.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The figure details the schedule of enrolment, interventions and assessments of BEAT DB trial in accordance with the Standard Protocol Items: Recommendations for Interventional Trials template. BEAT DB trial: this acronym is used in ClinicalTrial.gov registration. aPrimary endpoint is at 6 months follow-up. bData collection of medication usage from baseline before allocation throughout until 12 months after allocation will be done at 12-months follow-up. BEAT DB, Breathing Exercises in Asthma Targeting Dysfunctional Breathing; PROM, patient-reported outcome measures.
Figure 2
Figure 2
Patient flow through the RCT BEAT DB trial. Consolidated Standards of Reporting Trials (CONSORT) flow diagram 2010. BEAT DB, Breathing Exercises in Asthma Targeting Dysfunctional Breathing; ACQ6, asthma control questionnaire; BrEX, breathing exercises; MiniAQLQ, miniasthma quality of life questionnaire; RCT, randomised controlled trial; UC, usual specialist care.

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