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

Abstract

BackgroundChronic 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.ObjectiveTo assess the feasibility of recruiting patients, collecting data and delivering EPR to patients with AECOPD to evaluate EPR compared with usual care.DesignParallel-group, pilot 2 × 2 factorial randomised trial with nested qualitative research and an economic analysis.SettingTwo acute hospital NHS trusts. Recruitment was carried out from September 2015 to April 2016 and follow-up was completed in July 2016.ParticipantsEligible patients were those aged ≥ 35 years who were admitted with AECOPD, who were non-acidotic and who maintained their blood oxygen saturation level (SpO2) 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 (n = 14), (2) home EPR (n = 15), (3) hospital EPR and home EPR (n = 14) and (4) control (n = 15). Outcome assessors were blind to treatment allocation; it was not possible to blind patients.Main outcome measuresFeasibility 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 (n = 27) and research health professionals (n = 11), optimisation assessments and an economic analysis were also undertaken.ResultsOver 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,n = 5; home EPR,n = 6; hospital EPR and home EPR,n = 5; control,n = 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.ConclusionsA 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 registrationCurrent Controlled Trials ISRCTN18634494.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 11. See the NIHR Journals Library website for further project information.

Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

“…Overall, 5 of the 464 observed correlations were small (less than 0.10). Two of these small correlations came from the PRACTICE trial [26]. In this trial (PRACTICE) we observed a negative correlation of − 0.13 ( n = 36 participants) between the baseline and 3 months follow-up post-randomisation time point for the EQ-5D visual analogue scale (VAS) and 0.09 ( n = 42 participants) between the baseline and 1 month follow-up.…”

Exercise training for adults hospitalized with an acute respiratory condition: a systematic scoping review

“…Of the studies included in this review, 19 (95%) were published in peer-reviewed journals [2][3][4]12,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] and 1 (5%) was a published abstract for which further information was obtained from the author 34 (see Supplemental Table S1). These 20 studies described 16 unique randomized controlled trials, [2][3][4]12,[19][20][21][22][23][24][25][26][29][30][31]34 and 2 were single-group studies. 28,33 Two studies were qualitative analyses which utilized responses from participants recruited to two of the randomized controlled trials.…”

A Qualitative Study to Inform a More Acceptable Pulmonary Rehabilitation Program after Acute Exacerbation of Chronic Obstructive Pulmonary Disease

“…For example, in the studies by Eaton and colleagues (21) and Greening and colleagues (22), 57% and 27% of the eligible patients, respectively, declined participation in PR after AECOPD. The authors of a recent randomized, controlled trial (23), where patients completed early PR either at the hospital or at their home after hospitalization due to an AECOPD, concluded that recruitment and delivery of the intervention at the hospital was difficult. In this study, the home program was more acceptable.…”