Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD (PRIME)
Primary Purpose
COPD Exacerbation, COPD
Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COPD Exacerbation focused on measuring microbiota, pulmonary rehabilitation
Eligibility Criteria
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.
Sites / Locations
- University of AveiroRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary rehabilitation
Arm Description
Pulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation
Outcomes
Primary Outcome Measures
Change in exercise tolerance
exercise tolerance in a walking field test
Change in lung microbiota
lung microbiota from saliva samples
Secondary Outcome Measures
Change in muscle strength
Upper and lower limb muscle strength
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.
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.
Change in self-efficacy
self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool
Change in physical activity
Physical activity levels measured with the brief physical activity assessment tool
Change in lung function
Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp).
Change in emergency department visits
Number of emergency visits on the previous year
Change in frequency of exacerbations
Number of exacerbations on previous year
Change in hospitalizations
Number of hospitalizations on previous year
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03701945
Brief Title
Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
Acronym
PRIME
Official Title
Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, COPD
Keywords
microbiota, pulmonary rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Pulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Pulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support.
Primary Outcome Measure Information:
Title
Change in exercise tolerance
Description
exercise tolerance in a walking field test
Time Frame
Up to 6 months
Title
Change in lung microbiota
Description
lung microbiota from saliva samples
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
Upper and lower limb muscle strength
Time Frame
Up to 6 months
Title
Change in health related Quality of life
Description
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.
Time Frame
Up to 6 months
Title
Change in resting dyspnoea
Description
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.
Time Frame
Up to 6 months
Title
Change in self-efficacy
Description
self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool
Time Frame
Up to 6 months
Title
Change in physical activity
Description
Physical activity levels measured with the brief physical activity assessment tool
Time Frame
Up to 6 months
Title
Change in lung function
Description
Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp).
Time Frame
Up to 6 months
Title
Change in emergency department visits
Description
Number of emergency visits on the previous year
Time Frame
Up to 6 months
Title
Change in frequency of exacerbations
Description
Number of exacerbations on previous year
Time Frame
Up to 6 months
Title
Change in hospitalizations
Description
Number of hospitalizations on previous year
Time Frame
Up to 6 months
Title
Dyspnoea during exercise
Description
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.
Time Frame
Up to 6 months
Title
Fatigue during exercise
Description
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.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alda Marques, PhD
Phone
00351 234 372 462
Ext
27121
Email
amarques@ua.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alda Marques, PhD
Organizational Affiliation
School of Health Sciences, University of Aveiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aveiro
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alda S. Marques, PhD
Phone
00351 234 372 462
Email
amarques@ua.pt
First Name & Middle Initial & Last Name & Degree
Alda S. Marques, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35514131
Citation
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.
Results Reference
derived
Learn more about this trial
Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
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