Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 4
- 主要终点
- Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire)
研究概览
简要总结
A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program is feasible and effective even in the presence of complex comorbidities, although some combined diseases might reduce the overall proportion of patients who respond to pre-defined outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92).
The aim of this prospective study is to describe the pattern of prevalence of the most frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes, referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of COPD as defined and classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
- •Ability to perform a rehabilitation program.
排除标准
- •Patients with asthma or any other pulmonary diseases (either obstructive or restrictive.
- •Patients no able to complete a rehabilitation program
结局指标
主要结局
Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire)
时间窗: T0 (admission in hospital) - Tend (discharge, after 20 days)
Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD)
时间窗: T0 (admission in hospital) - Tend (discharge, after 20 days)
Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale)
时间窗: T0 (admission in hospital) - Tend (discharge, after 20 days)
次要结局
- Percentage of patients who withdrew from rehabilitation.(Tend (discharge, after 20 days))
- Prevalence of comorbidities associated to COPD(Tend (discharge, after 20 days))
研究者
Prof. Clini Enrico
Professor
Villa Pineta Hospital