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BMJ 2004;329:1209 (20 November), doi:10.1136/bmj.38258.662720.3A (published 25 October 2004)
William D-C Man, MRC clinical research fellow1, Michael I Polkey, consultant physician in respiratory medicine3, Nora Donaldson, senior lecturer in statistics2, Barry J Gray, consultant physician in respiratory medicine2, John Moxham, professor of respiratory medicine1
1 Respiratory Muscle Laboratory, Guy's, King's, and St Thomas' School of Medicine, King's College Hospital, London SE5 9PJ, 2 King's College Hospital, London SE5 9RS, 3 Royal Brompton Hospital, London SW3 6NP
Correspondence to: W D-C Man william.man{at}kcl.ac.uk
Design A single centre, randomised controlled trial.
Setting An inner city, secondary and tertiary care hospital in London.
Participants 42 patients admitted with an acute exacerbation of COPD.
Intervention An eight week, pulmonary rehabilitation programme for outpatients, started within 10 days of hospital discharge, or usual care.
Main outcome measures Incremental shuttle walk distance, disease specific health status (St George's respiratory questionnaire, SGRQ; chronic respiratory questionnaire, CRQ), and generic health status (medical outcomes short form 36 questionnaire, SF-36) at three months after hospital discharge.
Results Early pulmonary rehabilitation, compared with usual care, led to significant improvements in median incremental shuttle walk distance (60 metres, 95% confidence interval 26.6 metres to 93.4 metres, P = 0.0002), mean SGRQ total score (-12.7, -5.0 to -20.3, P = 0.002), all four domains of the CRQ (dyspnoea 5.5, 2.0 to 9.0, P = 0.003; fatigue 5.3, 1.9 to 8.8, P = 0.004; emotion 8.7, 2.4 to 15.0, P = 0.008; and mastery 7.5, 4.2 to 10.7, P < 0.001), and the mental component score of the SF-36 (20.1, 3.3 to 36.8, P = 0.02). Improvements in the physical component score of the SF-36 did not reach significance (10.6, -0.3 to 21.6, P = 0.057).
Conclusion Early pulmonary rehabilitation after admission to hospital for acute exacerbations of COPD is safe and leads to statistically and clinically significant improvements in exercise capacity and health status at three months.
850m).1 Exacerbations are also associated with impaired quality of life, reduced exercise capacity, and increased risk of readmission.2 Interventions designed to hasten recovery and improve symptoms after admission to hospital may lead not only to reduced use of health care in the future (and subsequent economic benefits to the NHS) but also to real improvements in quality of life and functional ability in breathless and vulnerable patients with COPD. Pulmonary rehabilitation is a multidisciplinary programme of care for patients with chronic respiratory impairment that is individually tailored and designed to optimise each patient's physical and social performance and autonomy. Pulmonary rehabilitation leads to statistically significant and clinically meaningful improvements in health related quality of life, functional exercise capacity, and maximum exercise capacity in patients with stable COPD.3 4 Consequently, the recent guidelines on the management of COPD published by the National Institute for Clinical Excellence (NICE) and the British Thoracic Society recommend that pulmonary rehabilitation should be made available to all appropriate patients.5 However, the effects of early pulmonary rehabilitation of outpatients in the acute recovery phase after hospital admission for acute exacerbations of COPD have not previously been studied.
We assessed the feasibility and safety of an early pulmonary rehabilitation programme for outpatients and determined the effects on exercise capacity and quality of life, compared with usual care, at three months after a hospital admission for acute exacerbation of COPD.
All admitted patients received standard treatment, including nebulised bronchodilators, oxygen, oral or intravenous antibiotics, non-invasive ventilation (if required), and a one to two week course of oral prednisolone (30-40 mg daily). On discharge from hospital, patients were allocated to either an early pulmonary rehabilitation programme (within 10 days of hospital discharge) or usual care, using the minimisation method
Assessment
We made baseline assessments in the 24 hours before patients were discharged from hospital and assigned to the intervention, and at three months.
We measured exercise capacity by the incremental shuttle walk test,6 a standardised, externally paced, corridor walking test, which is reproducible after a single practice walk. We used the St George's respiratory questionnaire (SGRQ) and the chronic respiratory disease questionnaire (CRQ). We measured generic health status with the medical outcomes short form 36 item questionnaire (SF-36).7
Owing to the nature of the intervention and financial and logistical considerations, it was not possible to blind the patients or the assessors.
Pulmonary rehabilitation
A multidisciplinary team ran the pulmonary rehabilitation programme, which consisted of two classes per week for eight weeks. Each class lasted two hours, consisting of one hour of exercise (aerobic walking and cycling, strength training for the upper and lower limb) and one hour of educational activities (with an emphasis on self management of the disease, nutrition, and lifestyle issues). Respiratory physiotherapists and nurses supervised the exercise component, as did health centre based fitness instructors. Physiotherapists, respiratory nurses, an occupational therapist, a dietician, a respiratory doctor, a smoking cessation adviser, a social worker, a pharmacist, and a lay member of a patients' group supervised education activities on a rolling rota. Patients also received individualised home exercise programmes, which encouraged at least 20 minutes of exercise per day.
Exercise capacity, the SGRQ impacts and total score, all four domains of the CRQ, and the mental component score of the SF-36 improved significantly in favour of early pulmonary rehabilitation (table). The magnitude of these mean improvements greatly exceeded the recognised minimal clinically important differences for these measures. In addition, the rehabilitation group made far fewer visits to accident and emergency departments, and there was a trend towards reduced hospital readmission rate and fewer hospital days.
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Comparison with other studies
Excellent evidence supports the benefits of pulmonary rehabilitation in stable patients with COPD.3
4 This study examines the effects of this outpatient intervention in patients during the early recovery period after a hospital admission for an acute exacerbation. Despite optimal medical treatment during hospital admission, patients at discharge take considerable time to recover to baseline levels of physical functioning and health status. Previous studies have shown that up to 25% of patients after an acute exacerbation do not fully recover to baseline peak flow at three months8 and that the recovery period in health status is long even in patients who do not have further exacerbations.9 Our data indicate that patients can safely participate in a community based pulmonary rehabilitation programme for outpatients shortly after an exacerbation and that such a programme speeds up recovery from the debilitating effects of a hospital admission. Furthermore, the magnitude of the effects of early pulmonary rehabilitation on exercise capacity and health status are considerably greater than, and in addition to, the effects of bronchodilator or corticosteroid therapy.10
Limitations of the study
The study did not explore the mechanisms by which early pulmonary rehabilitation achieves its effects. Possible explanations include physiological improvements in skeletal muscle function, desensitisation to dyspnoea, and psychosocial lifestyle changes. Another limitation of the study is that the assessors were not fully blinded to treatment allocation as they may have been directly or indirectly involved in the delivery of the intervention. This may introduce an element of bias to the results.
Possible health economic impact and outlook
The a priori primary outcome measures were exercise capacity, as measured by the incremental shuttle walk, and health status. However, secondary outcome measures included use of hospital resources, and fewer visits were made to the accident and emergency department in the group undergoing early pulmonary rehabilitation. Patients in the treated group were readmitted 30% less often than patients in the control group, and there was a trend towards fewer hospital inpatient days. The results therefore imply that early pulmonary rehabilitation may reduce usage of healthcare resources and bring improvements in exercise capacity and health status.
Larger randomised studies are required to determine whether the benefits of early pulmonary rehabilitation translate into improved health economics. Other unanswered questions include the long term effects of early pulmonary rehabilitation, and the optimal structure, location, and duration of pulmonary rehabilitation programmes.
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Despite medical optimisation during hospital admission for acute exacerbations of COPD, early pulmonary rehabilitation after discharge from hospital leads to additional notable improvements in exercise capacity and health status at three months compared with usual care.
This is the abridged version of an article that was posted on bmj.com on 25 October 2004: http://bmj.com/cgi/doi/10.1136/bmj.38258.662720.3A
The CONSORT checklist of items to include when reporting a randomised controlled trial is on bmj.com
We thank the Southwark and Lambeth pulmonary rehabilitation team for running and supervising the rehabilitation programme described in this work.
Funding: This study was supported by a British Lung Foundation Trevor Clay Memorial Grant. WD-CM is a clinical research training fellow of the Medical Research Council (UK). The Southwark and Lambeth pulmonary rehabilitation team is in part funded by "Pursuing Perfection," coordinated by the NHS Modernisation Agency
Competing interests: None declared.
Ethical approval: The local research ethics committee approved the study.
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