The feasibility of early pulmonary rehabilitation and activity after COPD exacerbations: external pilot randomised controlled trial, qualitative case study and exploratory economic evaluation.

Cox, Matthew and O'Connor, Catherine and Biggs, Katie and Hind, Daniel and Bortolami, Oscar and Franklin, Matthew and Collins, Barbara and Walters, Stephen and Wailoo, Allan and Channell, Julie and Albert, Paul and Freeman, Ursula and Bourke, Stephen and Steiner, Michael and Miles, Jon and O'Brien, Tom and McWilliams, David and Schofield, Terry and O'Reilly, John and Hughes, Rodney (2018) The feasibility of early pulmonary rehabilitation and activity after COPD exacerbations: external pilot randomised controlled trial, qualitative case study and exploratory economic evaluation. Health technology assessment (Winchester, England), 22 (11). pp. 1-204. ISSN 2046-4924.

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Abstract

BACKGROUND

Chronic obstructive pulmonary disease (COPD) affects > 3 million people in the UK. Acute exacerbations of COPD (AECOPD) are the second most common reason for emergency hospital admission in the UK. Pulmonary rehabilitation is usual care for stable COPD but there is little evidence for early pulmonary rehabilitation (EPR) following AECOPD, either in hospital or immediately post discharge.

OBJECTIVE

To assess the feasibility of recruiting patients, collecting data and delivering EPR to patients with AECOPD to evaluate EPR compared with usual care.

DESIGN

Parallel-group, pilot 2 × 2 factorial randomised trial with nested qualitative research and an economic analysis.

SETTING

Two acute hospital NHS trusts. Recruitment was carried out from September 2015 to April 2016 and follow-up was completed in July 2016.

PARTICIPANTS

Eligible patients were those aged ≥ 35 years who were admitted with AECOPD, who were non-acidotic and who maintained their blood oxygen saturation level (pO) within a prescribed range. Exclusions included the presence of comorbidities that affected the ability to undertake the interventions.

INTERVENTIONS

(1) Hospital EPR: muscle training delivered at the patient's hospital bed using a cycle ergometer and (2) home EPR: a pulmonary rehabilitation programme delivered in the patient's home. Both interventions were delivered by trained physiotherapists. Participants were allocated on a 1 : 1 : 1 : 1 ratio to (1) hospital EPR ( = 14), (2) home EPR ( = 15), (3) hospital EPR and home EPR ( = 14) and (4) control ( = 15). Outcome assessors were blind to treatment allocation; it was not possible to blind patients.

MAIN OUTCOME MEASURES

Feasibility of recruiting 76 participants in 7 months at two centres; intervention delivery; views on intervention/research acceptability; clinical outcomes including the 6-minute walk distance (6WMD); and costs. Semistructured interviews with participants ( = 27) and research health professionals ( = 11), optimisation assessments and an economic analysis were also undertaken.

RESULTS

Over 7 months 449 patients were screened, of whom most were not eligible for the trial or felt too ill/declined entry. In total, 58 participants (76%) of the target 76 participants were recruited to the trial. The primary clinical outcome (6MWD) was difficult to collect (hospital EPR,  = 5; home EPR,  = 6; hospital EPR and home EPR,  = 5; control,  = 5). Hospital EPR was difficult to deliver over 5 days because of patient discharge/staff availability, with 34.1% of the scheduled sessions delivered compared with 78.3% of the home EPR sessions. Serious adverse events were experienced by 26 participants (45%), none of which was related to the interventions. Interviewed participants generally found both interventions to be acceptable. Home EPR had a higher rate of acceptability, mainly because patients felt too unwell when in hospital to undergo hospital EPR. Physiotherapists generally found the interventions to be acceptable and valued them but found delivery difficult because of staffing issues. The health economic analysis results suggest that there would be value in conducting a larger trial to assess the cost-effectiveness of the hospital EPR and hospital EPR plus home EPR trial arms and collect more information to inform the hospital cost and quality-adjusted life-year parameters, which were shown to be key drivers of the model.

CONCLUSIONS

A full-scale randomised controlled trial using this protocol would not be feasible. Recruitment and delivery of the hospital EPR intervention was difficult. The data obtained can be used to design a full-scale trial of home EPR. Because of the small sample and large confidence intervals, this study should not be used to inform clinical practice.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN18634494.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 11. See the NIHR Journals Library website for further project information.

Item Type: Article
Subjects: WF Respiratory system. Respiratory medicine
Divisions: Clinical Support > Critical Care
Related URLs:
Depositing User: Jennifer Manders
Date Deposited: 12 Apr 2019 15:50
Last Modified: 12 Apr 2019 15:50
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/2025

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