Objective To obtain evidence whether the online pulmonary rehabilitation(PR) programme ‘my-PR’ is non-inferior to a conventional face-to-face PR in improving physical performance and symptom scores in patients with COPD.
Design A two-arm parallel single-blind, randomised controlled trial.
Setting The online arm carried out pulmonary rehabilitation in their own homes and the face to face arm in a local rehabilitation facility.
Participants 90 patients with a diagnosis of chronic obstructive pulmonary disease (COPD), modified Medical Research Council score of 2 or greater referred for pulmonary rehabilitation (PR), randomised in a 2:1 ratio to online (n=64) or face-to-face PR (n=26). Participants unable to use an internet-enabled device at home were excluded.
Main outcome measures Coprimary outcomes were 6 min walk distance test and the COPD assessment test (CAT) score at completion of the programme.
Interventions A 6-week PR programme organised either as group sessions in a local rehabilitation facility, or online PR via log in and access to 'myPR’.
Results The adjusted mean difference for the 6 min walk test (6MWT) between groups for the intention-to-treat (ITT) population was 23.8 m with the lower 95% CI well above the non-inferiority threshold of −40.5 m at −4.5 m with an upper 95% CI of +52.2 m. This result was consistent in the per-protocol (PP) population with a mean adjusted difference of 15 m (−13.7 to 43.8). The CAT score difference in the ITT was −1.0 in favour of the online intervention with the upper 95% CI well below the non-inferiority threshold of 1.8 at 0.86 and the lower 95% CI of −2.9. The PP analysis was consistent with the ITT.
Conclusion PR is an evidenced-based and guideline-mandated intervention for patients with COPD with functional limitation. A 6-week programme of online-supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of effects on 6MWT distance, and symptom scores and was safe and well tolerated.
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Contributors RDV, MN, SCB, VC and TW contributed to the study design. BG was principal investigator. RDV, MN, BG, TB and AJC contributed to the study delivery. VC analysed the data. All authors contributed to data interpretation and manuscript preparation and reviewed the final draft. TW is guarantor for the data.
Funding The study was funded by a Small Business Research Initiative (SBRI) grant from NHS England.
Competing interests Dr Bourne reports grants and personal fees from myMHealth (a medical software company) during the conduct of the study; other from myMHealth, outside the submitted work. He is CEO, co-founder and part owner of this company. Mrs De Vos reports personal fees from myMHealth, during the conduct of the study; and is a partner in the rehabilitation facility that hosted some of the clinical trial activity. Dr Green reports grants to Portsmouth Hospitals NHS Trust from myMHealth, during the conduct of the study. Mr North has nothing to disclose. Dr Cornelius reports personal fees from myMHealth, during the conduct of the study. Professor Chauhan has nothing to disclose. Dr Brown reports grants from myMHealth, during the conduct of the study. Professor Wilkinson reports grants and personal fees from myMHealth during the conduct of the study. He is co-founder and part owner of this company.
Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval This study was approved by the research ethics committee for Berkshire B of the UK Health Research Authority (15/SC/0345).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All anonymised trial data are available on application to the senior author.
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