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

BackgroundAsthma 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.ObjectivesTo 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.DesignParallel-group three-arm randomised controlled trial.SettingGeneral practice surgeries in the UK.ParticipantsIn 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.InterventionsPhysiotherapy-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 measuresThe 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.ResultsPrimary 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.ConclusionsOnly 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 registrationCurrent Controlled Trials ISRCTN88318003.FundingThis project was primarily funded by the NIHR Health Technology Assessment programme and will be published in full inHealth 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.

Physiotherapy breathing retraining for asthma: a randomised controlled trial

“…The economic assessment is reported in detail elsewhere, 14 but showed that both interventions were better than usual care (ie, they resulted in superior outcomes at lower total cost). This finding applied both to AQLQ and quality-adjusted life-year (QALY) comparisons but only the improvement in AQLQ was significant.…”

“…In our pragmatic randomised trial, we confirmed that three sessions of face-to-face physiotherapist-taught breathing exercises improve disease-related quality of life for adults with asthma, and we have also shown that equivalent improvements can be achieved from a self-guided digital audiovisual programme. This programme was cost-effective 14 and was considered to be an acceptable intervention method by patients.…”

“…A pre-specified health economic assessment was done by assessing the intervention provision costs, and mean health service use cost per patient by treatment group, aggregated from the costs of asthma-related prescriptions, consultations, and hospital admissions, and is reported in full elsewhere. 14 …”

“…The economic evaluation report followed the CHEERS guideline. 14 Adverse events in the full intention-to-treat population were reported by the local investigators and also gathered from the routine medical record at the end of the study by research nurses masked to the participants randomisation group. All significant (fatal or potentially life-threatening) events were collected, and all adverse events resulting in medical attention that could plausibly be related to the study intervention were included, in the following categories: asthma-related; respiratory (including infections); ear, nose and throat; musculoskeletal; abdominal; neurological; and psychiatric events, detailed in the full study report.…”

“…All significant (fatal or potentially life-threatening) events were collected, and all adverse events resulting in medical attention that could plausibly be related to the study intervention were included, in the following categories: asthma-related; respiratory (including infections); ear, nose and throat; musculoskeletal; abdominal; neurological; and psychiatric events, detailed in the full study report. 14 …”