Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
- Conditions
- COPD ExacerbationCOPD
- Interventions
- Other: Pulmonary rehabilitation
- Registration Number
- NCT03701945
- Lead Sponsor
- Aveiro University
- Brief Summary
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.
- Detailed Description
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.
PRIME will contribute to optimise outcomes, improve AECOPD healthcare services and reduce the burden with COPD.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 156
- Patients are eligible if adults (≥18anos) and present a diagnose of chronic obstructive pulmonary disease (COPD).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Pulmonary rehabilitation Pulmonary rehabilitation Pulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation
- Primary Outcome Measures
Name Time Method Change in exercise tolerance Up to 6 months exercise tolerance in a walking field test
Change in lung microbiota Up to 6 months lung microbiota from saliva samples
- Secondary Outcome Measures
Name Time Method Change in hospitalizations Up to 6 months Number of hospitalizations on previous year
Change in frequency of exacerbations Up to 6 months Number of exacerbations on previous year
Change in muscle strength Up to 6 months Upper and lower limb muscle strength
Change in resting dyspnoea Up to 6 months Resting dyspnoea measured with the modified British medical research council dyspnoea questionnaire, that ranges from 0 to 4, and is related to dyspnoea during activities of daily living. Higher scores demonstrate a higher functional impairment due to dyspnoea.
Change in emergency department visits Up to 6 months Number of emergency visits on the previous year
Dyspnoea during exercise Up to 6 months Dyspnoea experienced during exercise, monitored with the modified Borg dyspnoea scale, that ranges from 0 to 10, where 0 represents no dyspnoea and 10 the worst imaginable dyspnoea.
Change in self-efficacy Up to 6 months self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool
Change in lung function Up to 6 months Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp).
Change in health related Quality of life Up to 6 months Measured with the St. George's Respiratory Questionnaire, that measures health related quality of life. It will be used the total score. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
Change in physical activity Up to 6 months Physical activity levels measured with the brief physical activity assessment tool
Fatigue during exercise Up to 6 months Fatigue experienced during exercise, monitored with the modified Borg dyspnoea scale, that ranges from 0 to 10, where 0 represents no fatigue and 10 the worst fatigue the patient can imagine.
Trial Locations
- Locations (1)
University of Aveiro
🇵🇹Aveiro, Portugal