Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD (PRIME)

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.

Study Overview

• Status: Unknown
• Conditions: COPD; COPD Exacerbation
• Intervention / Treatment: Other: Pulmonary rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal, 3810-193
    • Recruiting
    • University of Aveiro
    • Contact: Alda S. Marques, PhD; Phone Number: 00351 234 372 462; Email: amarques@ua.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pulmonary rehabilitation; Pulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise tolerance	exercise tolerance in a walking field test	Up to 6 months
Change in lung microbiota	lung microbiota from saliva samples	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle strength	Upper and lower limb muscle strength	Up to 6 months
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
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
Change in self-efficacy	self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool	Up to 6 months
Change in physical activity	Physical activity levels measured with the brief physical activity assessment tool	Up to 6 months
Change in lung function	Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp).	Up to 6 months
Change in emergency department visits	Number of emergency visits on the previous year	Up to 6 months
Change in frequency of exacerbations	Number of exacerbations on previous year	Up to 6 months
Change in hospitalizations	Number of hospitalizations on previous year	Up to 6 months
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
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

Collaborators and Investigators

• Sponsor: Aveiro University
• Investigators: Principal Investigator: Alda Marques, PhD, School of Health Sciences, University of Aveiro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; microbiota
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: POCI-01-0145-FEDER-028806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No