Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed-methods Approach

NCT03751670

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

UNKNOWN NA

Early Pulmonary Rehabilitation for Hospitalized Patients With Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

NCT00287625

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

NCT04722224

COPD

RECRUITING NA

Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients

NCT05315505

Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation

UNKNOWN NA

(Re)Vitalizing Pulmonary Rehabilitation for Patients With Chronic Respiratory Diseases

NCT03799666

Chronic Respiratory Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulmonary rehabilitation

Pulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation

Group Type EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type OTHER

Pulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulmonary rehabilitation

Pulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No