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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

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
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

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.

asthma, asthma control, asthma quality of life questionnaire, breathing exercises, dysfunctional breathing, physiotherapist-delivered breathing retraining
2044-6055
Andreasson, Karen Hjerrild
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Skou, Søren Thorgaard
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Ulrik, Charlotte Suppli
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Madsen, Hanne
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Sidenius, Kirsten
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Jacobsen, Jannie Søndergaard
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Assing, Karin Dahl
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Rasmussen, Kirsten Brændholt
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Porsbjerg, Celeste
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Thomas, Mike
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Bodtger, Uffe
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Andreasson, Karen Hjerrild
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Skou, Søren Thorgaard
4d6270f8-d980-4b80-a5ed-a2b7f06ca3d9
Ulrik, Charlotte Suppli
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Madsen, Hanne
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Sidenius, Kirsten
df3521de-766b-4e9a-8c6f-5f725d2d49f9
Jacobsen, Jannie Søndergaard
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Assing, Karin Dahl
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Rasmussen, Kirsten Brændholt
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Porsbjerg, Celeste
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Thomas, Mike
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Bodtger, Uffe
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Andreasson, Karen Hjerrild, Skou, Søren Thorgaard, Ulrik, Charlotte Suppli, Madsen, Hanne, Sidenius, Kirsten, Jacobsen, Jannie Søndergaard, Assing, Karin Dahl, Rasmussen, Kirsten Brændholt, Porsbjerg, Celeste, Thomas, Mike and Bodtger, Uffe (2019) 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. BMJ Open, 9 (12), [e032984]. (doi:10.1136/bmjopen-2019-032984).

Record type: Article

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.

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More information

Accepted/In Press date: 19 November 2019
e-pub ahead of print date: 31 December 2019
Keywords: asthma, asthma control, asthma quality of life questionnaire, breathing exercises, dysfunctional breathing, physiotherapist-delivered breathing retraining

Identifiers

Local EPrints ID: 437194
URI: http://eprints.soton.ac.uk/id/eprint/437194
ISSN: 2044-6055
PURE UUID: c19cf97a-1a17-4866-8476-eff6be12af3b

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Date deposited: 21 Jan 2020 17:35
Last modified: 05 Jun 2024 18:59

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Contributors

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

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