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

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 (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 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 (n = 27) and research health professionals (n = 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,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. 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 inHealth Technology Assessment; Vol. 22, No. 11. See the NIHR Journals Library website for further project information

Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

With an ever-expanding understanding about chronic obstructive pulmonary disease (COPD), it has been realized that it is a respiratory disease with systemic manifestations. Systemic effects of COPD lead to cardiovascular co-morbidities, muscle wasting and osteoporosis that in turn lead to inactivity and physical deconditioning. This development has a direct impact on the health-related quality of life (HRQoL) of patients suffering from this respiratory disease. Pharmacological therapy leads to improvement in shortness of breath and has limited effect on the physical deconditioning. Latest research has shown an additive effect of pulmonary rehabilitation on improving the inactivity and overall HRQoL in COPD patients. Pulmonary rehabilitation (PR) is a comprehensive multimodality program that includes strength and endurance training, nutritional education and psychosocial support. This leads to a holistic approach to management of COPD which results in symptom improvement in patients and decreased utilization of heath care resources. There are several barriers to widespread adoption of pulmonary rehabilitation as a standard treatment. This includes availability, insurance coverage and patient compliance. With inclusion of pulmonary rehabilitation in respiratory society guidelines, there has been a renewed interest among both pulmonary specialist and community physicians. This chapter aims to provide exhaustive evidence based knowledge regarding pulmonary rehabilitation and its beneficial effect on COPD patients