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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.
Health Technol Assess 2017; 21(53):1-162HT

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.

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.

Authors+Show Affiliations

Faculty of Medicine, University of Southampton, Southampton, UK.Faculty of Health Sciences, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.School of Psychology, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Asthma UK, London, UK.Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.Nuffield Department of Medicine, University of Oxford, Oxford, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.School of Psychology, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Department of Psychology, Bournemouth University, Bournemouth, UK.Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.Patient and public involvement representative.Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28944752

Citation

Thomas, Mike, et al. "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 (Winchester, England), vol. 21, no. 53, 2017, pp. 1-162.
Thomas M, Bruton A, Little P, et al. 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 Technol Assess. 2017;21(53):1-162.
Thomas, M., Bruton, A., Little, P., Holgate, S., Lee, A., Yardley, L., ... 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 (Winchester, England), 21(53), pp. 1-162. doi:10.3310/hta21530.
Thomas M, et al. 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 Technol Assess. 2017;21(53):1-162. PubMed PMID: 28944752.
* Article titles in AMA citation format should be in sentence-case
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, PY - 2017/9/26/entrez PY - 2017/9/26/pubmed PY - 2018/7/17/medline SP - 1 EP - 162 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 21 IS - 53 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. 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. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/28944752/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_ L2 - https://doi.org/10.3310/hta21530 DB - PRIME DP - Unbound Medicine ER -