Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

NCT03701945 | Unknown

• 1 other identifier: POCI-01-0145-FEDER-028806
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation; COPD

Keywords

microbiota; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Change in muscle strength

  Up to 6 months

• Change in health related Quality of life

  Up to 6 months

• Change in resting dyspnoea

  Up to 6 months

• Change in self-efficacy

  Up to 6 months

• Change in physical activity

  Up to 6 months

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL

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

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation OTHER

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

Pulmonary rehabilitation

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

RECRUITING

Related Publications (1)

• 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.

  PMID: 35514131 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alda Marques, PhD

  School of Health Sciences, University of Aveiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alda Marques, PhD

CONTACT

00351 234 372 462; amarques@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 10, 2018
• Study Start: October 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)