Clinical trial NCT03701945: Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
Official title: Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
COPD
Keywords: microbiota
pulmonary rehabilitation
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 156
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients are eligible if adults (≥18anos) and present a diagnose of chronic obstructive pulmonary disease (COPD).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in exercise tolerance
timeFrame: Up to 6 months
measure: Change in lung microbiota
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in muscle strength
timeFrame: Up to 6 months
measure: Change in health related Quality of life
timeFrame: Up to 6 months
measure: Change in resting dyspnoea
timeFrame: Up to 6 months
measure: Change in self-efficacy
timeFrame: Up to 6 months
measure: Change in physical activity
timeFrame: Up to 6 months
measure: Change in lung function
timeFrame: Up to 6 months
measure: Change in emergency department visits
timeFrame: Up to 6 months
measure: Change in frequency of exacerbations
timeFrame: Up to 6 months
measure: Change in hospitalizations
timeFrame: Up to 6 months
measure: Dyspnoea during exercise
timeFrame: Up to 6 months
measure: Fatigue during exercise
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: School of Health Sciences, University of Aveiro
name: Alda Marques, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.