Early Pulmonary Rehabilitation (PR) Following Hospitalisation For Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death)
研究概览
简要总结
The principal aim of the study is to evaluate whether attendance at an exercise training and education programme (known as pulmonary rehabilitation) shortly following hospital discharge can lead to a reduction in exacerbations and improvement in exercise capacity and quality of life in patients with chronic obstructive pulmonary disease.
详细描述
Background:
Chronic obstructive pulmonary disease (COPD), also sometimes known as chronic asthma, bronchitis or emphysema, is an important health problem. Many people with COPD are admitted into hospital with a worsening of their symptoms, known as an exacerbation. Hospitalisations for acute exacerbations of chronic obstructive pulmonary disease (COPD) are a massive burden to the NHS. Over the past decade, these hospitalizations have increased by 50%, and annual hospital costs for COPD in the UK amount to more than £587 million. After being discharged, some people fail to cope very well due to a variety of reasons. A prolonged stay in hospital may lead to muscle weakness, particularly of the leg muscles [1], a loss of confidence in performing everyday activities, and increased anxiety [2]. A high proportion of these patients are re-admitted to hospital following discharge. The aim of the study is to assess whether attendance at an exercise training and education programme shortly following discharge can firstly, improve exercise capacity and quality of life, and secondly, reduce the use of health resources and costs to the NHS.
It is known that an exercise training and education programme known as Pulmonary Rehabilitation is beneficial to stable patients with COPD by reducing breathlessness, increasing exercise capacity and improving quality of life. We have recently performed a pilot study that has shown that early Pulmonary Rehabilitation has considerable short-term benefits in patients with COPD who have been recently discharged following a hospital admission for worsening of their symptoms [3]. We hypothesise that these benefits are long-lasting, and may reduce use of healthcare resources and costs to the NHS.
References:
- Spruit, M.A., et al., Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I. Thorax, 2003. 58(9): p. 752-6.
- Seemungal, T.A., et al., Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med, 1998. 157(5 Pt 1): p. 1418-22.
- Man, W.D., et al., Community pulmonary rehabilitation after hospitalisation for acute exacerbations of chronic obstructive pulmonary disease: randomised controlled study. BMJ, 2004. 329(7476): p. 1209.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to King's College Hospital with a clinical diagnosis of acute exacerbation of COPD. Patients with radiological and microbiological evidence of pneumonia with co-existing COPD will also be included.
排除标准
- •Significant co-morbidity that could limit exercise training & testing: Patients unable to walk due to a comorbid neuromuscular or rheumatological condition; patients with severe sensory and cognitive impairment; patients with unstable angina or aortic valve disease in which exercise could be dangerous.
- •Attendance at a pulmonary rehabilitation programme in the preceding year.
结局指标
主要结局
Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death)
时间窗: 3-months
次要结局
- Weight and fat free mass (electrical bioimpedance)(3-months and 1-year)
- Quadriceps muscle strength (volitional and non-volitional)(3-months and 1-year)
- Cost-effectiveness (Index derived from EQ-5D)(3-months and 1-year)
- Disease specific quality of life (CRDQ and SGRQ)(3 months and 1-year)
- Maximal walking capacity (ISW)and endurance walking capacity (ESW)(3-months and 1-year)