Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

COPD Clinical Trial

— PRIME  

Official title:

Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701945
• Other study ID #: POCI-01-0145-FEDER-028806
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Aveiro University
• Contact: Alda Marques, PhD
• Phone: 00351 234 372 462
• Email: amarques[@]ua.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Portugal	University of Aveiro	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise tolerance	exercise tolerance in a walking field test	Up to 6 months
Primary	Change in lung microbiota	lung microbiota from saliva samples	Up to 6 months
Secondary	Change in muscle strength	Upper and lower limb muscle strength	Up to 6 months
Secondary	Change in health related Quality of life	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.	Up to 6 months
Secondary	Change in resting dyspnoea	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.	Up to 6 months
Secondary	Change in self-efficacy	self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool	Up to 6 months
Secondary	Change in physical activity	Physical activity levels measured with the brief physical activity assessment tool	Up to 6 months
Secondary	Change in lung function	Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp).	Up to 6 months
Secondary	Change in emergency department visits	Number of emergency visits on the previous year	Up to 6 months
Secondary	Change in frequency of exacerbations	Number of exacerbations on previous year	Up to 6 months
Secondary	Change in hospitalizations	Number of hospitalizations on previous year	Up to 6 months
Secondary	Dyspnoea during exercise	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.	Up to 6 months
Secondary	Fatigue during exercise	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.	Up to 6 months