Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Change in exercise tolerance
研究概览
简要总结
PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.
详细描述
PRIME aims to address these two gaps, establishing the role of microbiota and clinical data in predicting AECOPD and increasing the evidence on PR in AECOPD through the translation of PR guidelines to the community. Specifically, it aims to:
- Explore the longitudinal changes in microbiota and clinical data between stable and exacerbations periods;
- Establish the feasibility and short- and long-term effects of community-based PR for AECOPD;
- Define the characteristics of patients who most benefit from community-based PR.
156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR. A clinical decision-making tool (CDMT) to prioritise patients with AECOPD for PR will be developed.
The experienced multidisciplinary team will ensure the following novel results:
- a clinical and lung microbiota profile of patients with COPD;
- a model of AECOPD prediction;
- recommendations for community-based PR in AECOPD;
- a CDMT to prioritise patients with AECOPD for PR.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible if adults (≥18anos) and present a diagnose of chronic obstructive pulmonary disease (COPD).
排除标准
- •Patients will be excluded if they had an acute cardiovascular event on the previous month or if they have a significant cardiac, immune, musculoskeletal or neurological impairment, or any other that doesn't allow them to perform tests.
结局指标
主要结局
Change in exercise tolerance
时间窗: Up to 6 months
exercise tolerance in a walking field test
Change in lung microbiota
时间窗: Up to 6 months
lung microbiota from saliva samples
次要结局
- Change in frequency of exacerbations(Up to 6 months)
- Change in muscle strength(Up to 6 months)
- Change in resting dyspnoea(Up to 6 months)
- Change in emergency department visits(Up to 6 months)
- Change in self-efficacy(Up to 6 months)
- Change in lung function(Up to 6 months)
- Dyspnoea during exercise(Up to 6 months)
- Change in health related Quality of life(Up to 6 months)
- Change in physical activity(Up to 6 months)
- Change in hospitalizations(Up to 6 months)
- Fatigue during exercise(Up to 6 months)
研究者
Alda Sofia Pires de Dias Marques
Principal Investigator
Aveiro University