COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Composite outcome of 1 year mortality or hospital readmission
研究概览
简要总结
Purpose: In a randomized controlled trial we will assess the effect of early pulmonary rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease (AECOPD).
详细描述
Background:
Pulmonary rehabilitation is a key element in treatment of stable COPD. A Cochrane review from 2011 showed that early pulmonary rehabilitation for COPD exacerbation 6-10 days after discharge, or during prolonged hospitalization significantly reduced mortality and hospitalizations without serious side effects. It consist of 9 small studies and larger RCT studies is required to establish the effect of early pulmonary rehabilitation.
AIM: The aim of the study is to investigate whether early pulmonary rehabilitation can reduce mortality og hospitalization in patients with acute exacerbation of COPD. Secondary increase exercise capacity, reduce symptoms and improve quality of life.
Methods:
Design: The study is a single center randomized, controlled, open label trial, with an intervention group and a control group. The patients are randomized to either a prespecified rehabilitation program, which is standardized to patients with COPD, or usual care. The patients' data are being recorded at baseline and visits at 2 and 6 months: Lung function (FEV1, FVC), CO in exhaled air, O2 saturation in the blood (and possibly O2 supplement), Heart Rate, Dyspnoea (Borg scale and Medical Research Council (MRC scale)), Quality of life (CAT), Walk Test (ISWT and ESWT), Daily medication, Outdoor activity. Information on mortality, hospital admissions, emergency room visits after 6 and 12 months is obtained from relevant databases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to hospital with acute exacerbation of COPD to Department Respiratory Medicine, Gentofte Hospital
- •Verified diagnosis of COPD FEV1/FVC <70 % in stable phase.
- •Expected discharge to their own home.
- •Minimal of 10 meters walking distance independently
- •Oral and written consent
- •Age > 18 year
排除标准
- •Life expectancy <6 months due to another illness (cancer, severe heart disease, etc.)
- •Difficulties in understanding and speaking Danish (eg. due to dementia)
- •Place of residence outside Gentofte Hospital admission area
结局指标
主要结局
Composite outcome of 1 year mortality or hospital readmission
时间窗: 12 months
It is all cause mortality in 12 months follow-up period.. Readmission is the proportion of patients with at least 1 hospital readmission in 12 months follow-up period. Intention-to-treat analysis.Secondarily per-protocol analysis.
次要结局
- All cause mortality and time to death(12 months)
- Hospital readmission by respiratory cause(12 months)
- Exercise performance(6 months)
- All cause hospital readmission and time to readmission(12 months)
- Health related quality of life(6 months)
- Dyspnea(6 months)
研究者
Jon Torgny Wilcke
Associate Professor, Pricipal Investigator
University Hospital, Gentofte, Copenhagen