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Abstract
Background Chronic obstructive pulmonary disease (COPD) is characterised by symptomatic dyspnoea and reduced exercise tolerance, in part as a result muscle weakness, for which inspiratory muscle training (IMT) may be useful. Excess mucus hypersecretion commonly coexists in COPD and may lead to reduce ventilation, further impacting on breathlessness. Devices for sputum clearance may be employed to aid mucus expectoration. This trial aimed to explore the effectiveness of a combined IMT and high-frequency airway oscillating (HFAO) device in the management of dyspnoea.
Methods This was a double-blinded, randomised sham-controlled trial which recruited symptomatic patients with COPD. Patients were randomised to either a HFAO device (Aerosure) or sham device for 8 weeks, three times a day. The primary outcome was the Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain. Pre-specified subgroup analyses were performed including those with respiratory muscle weakness, excessive sputum and frequent exacerbators.
Results 104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing. No difference in CRQ-D was seen between groups (0·28, 95% CI −0.19 to 0.75, p=0.24), though meaningful improvements were seen over time in both groups (mean (SD) HFAO 0.45 (0.78), p<0.01; sham 0.73 (1.09), p<0.01). Maximal inspiratory pressure significantly improved in the HFAO group over sham (5.26, 95% CI 0.34 to 10.19, p=0.05). Similar patterns were seen in the subgroup analysis.
Conclusion There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.
Trial registration number ISRCTN45695543.
- respiratory muscles
- perception of asthma/breathlessness
- pulmonary rehabilitation
Data availability statement
Data are available upon reasonable request. Data can be shared upon reasonable request, however individual patient data will not be shared. Statistical analysis plan and protocol can be shared upon request.
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Data availability statement
Data are available upon reasonable request. Data can be shared upon reasonable request, however individual patient data will not be shared. Statistical analysis plan and protocol can be shared upon request.
Footnotes
Twitter @EnyaDaynesPT
Contributors ED, NG and SJS all contributed to the protocol development, study delivery and data analysis. ED prepared the manuscript and this was reviewed by NG and SJS. ED is acting as the guarantor, and accepts full responsibility for this work.
Funding This study was funded by Actegy LTD through an educational grant and supported by the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre—Respiratory Theme. NG is funded by a NIHR Post-Doctoral Fellowship (pdf-2017-10-052). The views expressed are those of the author(s) and not necessarily those of the NHS and NIHR or the Department of Health. Actegy LTD provided the trial devices and funded researchers to undertake the project, however they were not involved in recruitment or data analysis processes. Authors were not directly paid to produce this manuscript. Data included in this manuscript remains the property of the University Hospitals of Leicester (who sponsored this study) and the authors had full access and final responsibility to publish the results.
Competing interests ED was awarded an educational grant from Actegy LTD for this study.
Provenance and peer review Not commissioned; externally peer reviewed.
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