Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COPD
- COPD Exacerbation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Intervention Model: Sequential AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 125 years
- Gender
- Both males and females
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 clinica...
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.
Tracking Information
- NCT #
- NCT03701945
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alda Marques, PhD School of Health Sciences, University of Aveiro