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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
  1. Karen Hjerrild Andreasson1,2,
  2. Søren Thorgaard Skou1,3,
  3. Charlotte Suppli Ulrik4,5,
  4. Hanne Madsen6,
  5. Kirsten Sidenius7,
  6. Jannie Søndergaard Jacobsen8,
  7. Karin Dahl Assing9,
  8. Kirsten Brændholt Rasmussen10,
  9. Celeste Porsbjerg5,11,
  10. Mike Thomas12,
  11. Uffe Bodtger13,14
  1. 1 Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Naestved, Region Zealand, Denmark
  2. 2 Department for Regional Health Research, University of Southern Denmark, Odense, Syddanmark, Denmark
  3. 3 Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
  4. 4 Department of Respiratory Diseases, Hvidovre Hospital, Hvidovre, Denmark
  5. 5 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  6. 6 Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark
  7. 7 Allergy & Lung Clinic, Elsinore, (private specialised clinic), Helsingør, Denmark
  8. 8 Department of Physiotherapy and Occupational Therapy, and Pulmonary Disease Unit, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Midtjylland, Denmark
  9. 9 Department of Respiratory Medicine, Aalborg University Hospital, Aalborg, Denmark
  10. 10 Department of Respiratory Medicine, Zealand University Hospital Roskilde, Roskilde, Zealand, Denmark
  11. 11 Department of Respiratory Medicine, Respiratory Research Unit, Bispebjerg and Frederiksberg University Hospitals, Copenhagen, Denmark
  12. 12 Primary Care, Department for Population Sciences and Medical Education, University of Southampton, Southampton, UK
  13. 13 Department for Regional Health Research, Naestved Hospital, University of Southern Denmark, Naestved, Denmark
  14. 14 Department of Respiratory Medicine, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark
  1. Correspondence to Karen Hjerrild Andreasson; khad{at}regionsjaelland.dk

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.

  • asthma
  • asthma control
  • breathing exercises
  • physiotherapist-delivered breathing retraining
  • dysfunctional breathing
  • asthma quality of life questionnaire

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @KarenAndreasson, @STSkou

  • Contributors KHA, UB, STS and MT (Research group, ie, 'steering committee') contributed substantially to the concept and design of this trial. The chief investigator (KHA) developed manuals for recruitment, assessment, and treatment, written information, applications for grants, and approval assignments, made registry at ClinicalTrial.gov, introduced and supervised the recruitment, assessment, and treatment procedures to all involved physiotherapists and nurses, and led the data collection. UB, STS, and MT gave feedback. STS specifically contributed in description of the statistical analyses.KHA drafted the manuscript. All authors (KHA, STS, CSU, HM, KS, JSJ, KDA, KBR, CP, MT, and UB) provided intellectual feedback to the manuscript and approved the final version.

  • Funding The trial is funded by the following non-commercial funders: Naestved, Slagelse and Ringsted Hospitals’ Research Fund, Region Zealand Health Scientific Research Foundation, The Danish Foundation TrygFonden (ID: 117031), and the Association of Danish Physiotherapist’s Research Fund. STS is currently funded by the Independent Research Fund Denmark (DFF – 6110-00045) and the Lundbeck Foundation.

  • Disclaimer The funders have no part in the design of the trial and will not have any role in its execution, analyses, interpretation of results, or decision related to reports of the results. The funders did not have any role in this trial other than to provide funding.

  • 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.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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