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

*Corresponding author for this work

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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.

Original languageEnglish
Article numbere032984
JournalBMJ Open
Volume9
Issue number12
Number of pages12
ISSN2044-6055
DOIs
Publication statusPublished - 31. Dec 2019

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Denmark
Respiration
Randomized Controlled Trials
Quality of Life
Computer Security
Ethics Committees
Physical Therapists
Comorbidity
Primary Health Care
Outpatients
Guidelines
Exercise

Keywords

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

Cite this

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 ; Bodtger, Uffe. / 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. In: BMJ Open. 2019 ; Vol. 9, No. 12.
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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.",
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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. / 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; Bodtger, Uffe.

In: BMJ Open, Vol. 9, No. 12, e032984, 31.12.2019.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - 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

AU - Andreasson, Karen Hjerrild

AU - Skou, Søren Thorgaard

AU - Ulrik, Charlotte Suppli

AU - Madsen, Hanne

AU - Sidenius, Kirsten

AU - Jacobsen, Jannie Søndergaard

AU - Assing, Karin Dahl

AU - Rasmussen, Kirsten Brændholt

AU - Porsbjerg, Celeste

AU - Thomas, Mike

AU - Bodtger, Uffe

PY - 2019/12/31

Y1 - 2019/12/31

N2 - 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.

AB - 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.

KW - asthma

KW - asthma control

KW - asthma quality of life questionnaire

KW - breathing exercises

KW - dysfunctional breathing

KW - physiotherapist-delivered breathing retraining

U2 - 10.1136/bmjopen-2019-032984

DO - 10.1136/bmjopen-2019-032984

M3 - Journal article

C2 - 31892661

VL - 9

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 12

M1 - e032984

ER -