A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults

Mike Thomas, Anne Bruton, Paul Little, Stephen Holgate, Amanda Lee, Lucy Yardley, Steve George, James Raftery, Jennifer Versnel, David Price, Ian Pavord, Ratko Djukanovic, Michael Moore, Sarah Kirby, Guiqing Yao, Shihua Zhu, Emily Arden-Close, Manimekalai Thiruvothiyur, Frances Webley, Mark Stafford-Watson & 2 others Elizabeth Dixon, Lynda Taylor

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Abstract

Background Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used. Objectives To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of ‘face-to-face’ physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods. Design Parallel-group three-arm randomised controlled trial. Setting General practice surgeries in the UK. Participants In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD (n = 261), physiotherapist (n = 132) and control (usual care) (n = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded. Interventions Physiotherapy-based breathing retraining delivered through three ‘face-to-face’ respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care. Main outcome measures The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods. Results Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95% confidence interval (CI) 0.11 to 0.44; p < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95% CI 0.04 to 0.44; p < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95% CI –0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating ‘dominance’ for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group. Conclusions Only 10% of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled. Trial registration Current Controlled Trials ISRCTN88318003.
Original languageEnglish
Pages (from-to)1-196
Number of pages196
JournalHealth Technology Assessment
Volume21
Issue number53
DOIs
Publication statusPublished - 1 Sep 2017

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Breathing Exercises
Physical Therapists
Asthma
Quality of Life
Health Care Costs
Control Groups
Pamphlets
Confidence Intervals
Respiration
Outcome Assessment (Health Care)
Patient Participation
Costs and Cost Analysis
State Hospitals
Hyperventilation
Health Resources
Spirometry
Random Allocation
Internet
Population
Nitric Oxide

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A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults. / Thomas, Mike; Bruton, Anne; Little, Paul; Holgate, Stephen; Lee, Amanda; Yardley, Lucy; George, Steve; Raftery, James; Versnel, Jennifer; Price, David; Pavord, Ian; Djukanovic, Ratko; Moore, Michael; Kirby, Sarah; Yao, Guiqing; Zhu, Shihua; Arden-Close, Emily; Thiruvothiyur, Manimekalai; Webley, Frances; Stafford-Watson, Mark; Dixon, Elizabeth; Taylor, Lynda.

In: Health Technology Assessment, Vol. 21, No. 53, 01.09.2017, p. 1-196.

Research output: Contribution to journalArticle

Thomas, M, Bruton, A, Little, P, Holgate, S, Lee, A, Yardley, L, George, S, Raftery, J, Versnel, J, Price, D, Pavord, I, Djukanovic, R, Moore, M, Kirby, S, Yao, G, Zhu, S, Arden-Close, E, Thiruvothiyur, M, Webley, F, Stafford-Watson, M, Dixon, E & Taylor, L 2017, 'A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults', Health Technology Assessment, vol. 21, no. 53, pp. 1-196. https://doi.org/10.3310/hta21530
Thomas, Mike ; Bruton, Anne ; Little, Paul ; Holgate, Stephen ; Lee, Amanda ; Yardley, Lucy ; George, Steve ; Raftery, James ; Versnel, Jennifer ; Price, David ; Pavord, Ian ; Djukanovic, Ratko ; Moore, Michael ; Kirby, Sarah ; Yao, Guiqing ; Zhu, Shihua ; Arden-Close, Emily ; Thiruvothiyur, Manimekalai ; Webley, Frances ; Stafford-Watson, Mark ; Dixon, Elizabeth ; Taylor, Lynda. / A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults. In: Health Technology Assessment. 2017 ; Vol. 21, No. 53. pp. 1-196.
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title = "A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults",
abstract = "Background Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used. Objectives To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of ‘face-to-face’ physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods. Design Parallel-group three-arm randomised controlled trial. Setting General practice surgeries in the UK. Participants In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD (n = 261), physiotherapist (n = 132) and control (usual care) (n = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded. Interventions Physiotherapy-based breathing retraining delivered through three ‘face-to-face’ respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care. Main outcome measures The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods. Results Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95{\%} confidence interval (CI) 0.11 to 0.44; p < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95{\%} CI 0.04 to 0.44; p < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95{\%} CI –0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating ‘dominance’ for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group. Conclusions Only 10{\%} of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled. Trial registration Current Controlled Trials ISRCTN88318003.",
author = "Mike Thomas and Anne Bruton and Paul Little and Stephen Holgate and Amanda Lee and Lucy Yardley and Steve George and James Raftery and Jennifer Versnel and David Price and Ian Pavord and Ratko Djukanovic and Michael Moore and Sarah Kirby and Guiqing Yao and Shihua Zhu and Emily Arden-Close and Manimekalai Thiruvothiyur and Frances Webley and Mark Stafford-Watson and Elizabeth Dixon and Lynda Taylor",
note = "Funding This project was primarily funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 53. See the NIHR Journals Library website for further project information. Additional financial support was received from Comprehensive Local Research Networks.",
year = "2017",
month = "9",
day = "1",
doi = "10.3310/hta21530",
language = "English",
volume = "21",
pages = "1--196",
journal = "Health Technology Assessment",
issn = "1366-5278",
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TY - JOUR

T1 - A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults

AU - Thomas, Mike

AU - Bruton, Anne

AU - Little, Paul

AU - Holgate, Stephen

AU - Lee, Amanda

AU - Yardley, Lucy

AU - George, Steve

AU - Raftery, James

AU - Versnel, Jennifer

AU - Price, David

AU - Pavord, Ian

AU - Djukanovic, Ratko

AU - Moore, Michael

AU - Kirby, Sarah

AU - Yao, Guiqing

AU - Zhu, Shihua

AU - Arden-Close, Emily

AU - Thiruvothiyur, Manimekalai

AU - Webley, Frances

AU - Stafford-Watson, Mark

AU - Dixon, Elizabeth

AU - Taylor, Lynda

N1 - Funding This project was primarily funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 53. See the NIHR Journals Library website for further project information. Additional financial support was received from Comprehensive Local Research Networks.

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Background Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used. Objectives To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of ‘face-to-face’ physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods. Design Parallel-group three-arm randomised controlled trial. Setting General practice surgeries in the UK. Participants In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD (n = 261), physiotherapist (n = 132) and control (usual care) (n = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded. Interventions Physiotherapy-based breathing retraining delivered through three ‘face-to-face’ respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care. Main outcome measures The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods. Results Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95% confidence interval (CI) 0.11 to 0.44; p < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95% CI 0.04 to 0.44; p < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95% CI –0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating ‘dominance’ for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group. Conclusions Only 10% of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled. Trial registration Current Controlled Trials ISRCTN88318003.

AB - Background Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used. Objectives To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of ‘face-to-face’ physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods. Design Parallel-group three-arm randomised controlled trial. Setting General practice surgeries in the UK. Participants In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD (n = 261), physiotherapist (n = 132) and control (usual care) (n = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded. Interventions Physiotherapy-based breathing retraining delivered through three ‘face-to-face’ respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care. Main outcome measures The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods. Results Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95% confidence interval (CI) 0.11 to 0.44; p < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95% CI 0.04 to 0.44; p < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95% CI –0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating ‘dominance’ for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group. Conclusions Only 10% of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled. Trial registration Current Controlled Trials ISRCTN88318003.

U2 - 10.3310/hta21530

DO - 10.3310/hta21530

M3 - Article

VL - 21

SP - 1

EP - 196

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 53

ER -