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

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  • Karen Hjerrild Andreasson, Department for Regional Health Research, University of Southern Denmark, Odense, Syddanmark, Denmark.
  • ,
  • Søren Thorgaard Skou, Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Naestved, Region Zealand, Denmark., Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
  • ,
  • Charlotte Suppli Ulrik, Københavns Universitet
  • ,
  • Hanne Madsen, Syddansk Universitet
  • ,
  • Kirsten Sidenius, Allergy & Lung Clinic, Elsinore, (private specialised clinic), Helsingør, Denmark.
  • ,
  • Jannie Søndergaard Jacobsen
  • Karin Dahl Assing, Department of Respiratory Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Kirsten Brændholt Rasmussen, Department of Respiratory Medicine, Zealand University Hospital Roskilde, Roskilde, Zealand, Denmark.
  • ,
  • Celeste Porsbjerg, Department of Respiratory Medicine, Respiratory Research Unit, Bispebjerg and Frederiksberg University Hospitals, Copenhagen, Denmark.
  • ,
  • Mike Thomas, University of Southampton
  • ,
  • Uffe Bodtger, Department of Respiratory Medicine, Naestved-Slagelse-Ringsted Hospitals, Naestved, 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.

TRIAL REGISTRATION NUMBER: NCT03127059; Pre-results.

OriginalsprogEngelsk
Artikelnummere032984
TidsskriftBMJ Open
Vol/bind9
Nummer12
ISSN2044-6055
DOI
StatusUdgivet - 31 dec. 2019

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© 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.

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