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Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Usual care
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic obstructive pulmonary disease (COPD), Pulmonary rehabilitation, Computerized respiratory sounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
  • ≥ 18 years old;
  • clinical stability for 1 month prior to the study (no hospital admissions, exacerbations or changes in medication);
  • able to provide their own informed consent.

Exclusion Criteria:

  • presence of concomitant respiratory diseases;
  • presence of severe psychiatric conditions;
  • presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease.

Sites / Locations

  • University of Aveiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual care

Pulmonary rehabilitation

Arm Description

Patients will receive usual care from their general practitioners/pulmonologists.

Patients will enrol in a 12-week PR program consisting on exercise training (3 times a week) and psychoeducation (once a week).

Outcomes

Primary Outcome Measures

Change in respiratory sounds
Computerized respiratory sounds will be recorded with modified stethoscopes at seven chest locations: trachea; posterior right and left; anterior right and left and lateral right and left, as recommended by the Computerized Respiratory Sound Analysis (CORSA) guidelines.

Secondary Outcome Measures

Change in lung function
Lung function will be assessed with a spirometric test, following the American Thoracic Society/European Respiratory Society guidelines.
Change in exercise capacity
Exercise capacity will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines.
Change in quadriceps muscle strength
Quadriceps isotonic muscle strength will be assessed with the 1 repetition maximum (1-RM), following the American College of Sports Medicine guidelines.
Change in health-related quality of life
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Scores range from 0 to 100 and higher values indicate poorer quality of life.
Change in health services use
number of visits to casualty; number and duration of hospital admissions.

Full Information

First Posted
January 28, 2014
Last Updated
January 18, 2018
Sponsor
Aveiro University
Collaborators
Fundação para a Ciência e a Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT02050711
Brief Title
Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD
Official Title
Effects of Pulmonary Rehabilitation on Computerized Respiratory Sounds in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2009 (Actual)
Primary Completion Date
March 20, 2013 (Actual)
Study Completion Date
September 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
Collaborators
Fundação para a Ciência e a Tecnologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) has been based on systemic outcome measures, however, little is known about the effectiveness of this intervention on patients' lung function. The forced expiratory volume in one second (FEV1), despite of being the gold standard for assessing lung function in COPD, is poorly responsive to pulmonary rehabilitation. Thus, an objective and responsive outcome measure to assess the effect of pulmonary rehabilitation on lung function is needed. Computerized respiratory sounds have been found to be a more sensitive indicator, detecting and characterizing the severity of respiratory diseases before any other measure, however its potential to detect changes after pulmonary rehabilitation has never been explored. Therefore, this study aims to assess the effects of pulmonary rehabilitation on the characteristics of computerized respiratory sounds in patients with COPD. A randomized controlled study with one group undergoing pulmonary rehabilitation (n=25) and other group receiving standard care (n=25) will be conducted. The pulmonary rehabilitation program will included exercise training (3*week) and psychoeducation (1*week). Computerized respiratory sounds, lung function, exercise capacity, quadriceps muscle strength, health-related quality of life and health services use will be assessed in both groups, at baseline, immediately post-intervention and at follow-ups (3 and 6 months after PR). Descriptive and inferential statistics will be used. It is expected that significant changes occur on the characteristics of computerized respiratory sounds in patients enrolled in the pulmonary rehabilitation group, in comparison with patients receiving standard care. Thus, computerized respiratory sounds could provide a simple, objective and non-invasive measure to assess lung function changes after pulmonary rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic obstructive pulmonary disease (COPD), Pulmonary rehabilitation, Computerized respiratory sounds

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Other
Arm Description
Patients will receive usual care from their general practitioners/pulmonologists.
Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Patients will enrol in a 12-week PR program consisting on exercise training (3 times a week) and psychoeducation (once a week).
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary rehabilitation
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Change in respiratory sounds
Description
Computerized respiratory sounds will be recorded with modified stethoscopes at seven chest locations: trachea; posterior right and left; anterior right and left and lateral right and left, as recommended by the Computerized Respiratory Sound Analysis (CORSA) guidelines.
Time Frame
1 week prior intervention; 1, 12 and 24 weeks post intervention
Secondary Outcome Measure Information:
Title
Change in lung function
Description
Lung function will be assessed with a spirometric test, following the American Thoracic Society/European Respiratory Society guidelines.
Time Frame
1 week prior intervention; 1, 12 and 24 weeks post intervention
Title
Change in exercise capacity
Description
Exercise capacity will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines.
Time Frame
1 week prior intervention; 1, 12 and 24 weeks post intervention
Title
Change in quadriceps muscle strength
Description
Quadriceps isotonic muscle strength will be assessed with the 1 repetition maximum (1-RM), following the American College of Sports Medicine guidelines.
Time Frame
1 week prior intervention; 1, 12 and 24 weeks post intervention
Title
Change in health-related quality of life
Description
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Scores range from 0 to 100 and higher values indicate poorer quality of life.
Time Frame
1 week prior intervention; 1, 12 and 24 weeks post intervention
Title
Change in health services use
Description
number of visits to casualty; number and duration of hospital admissions.
Time Frame
1 week prior intervention; 1, 12 and 24 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria; ≥ 18 years old; clinical stability for 1 month prior to the study (no hospital admissions, exacerbations or changes in medication); able to provide their own informed consent. Exclusion Criteria: presence of concomitant respiratory diseases; presence of severe psychiatric conditions; presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alda S Marques, PhD
Organizational Affiliation
School of Health Sciences of the University of Aveiro (ESSUA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aveiro
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
24046460
Citation
Marques A, Oliveira A, Jacome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17. Erratum In: Respir Care. 2016 Jan;61(1):e1.
Results Reference
background
PubMed Identifier
24106321
Citation
Jacome C, Marques A. Pulmonary rehabilitation for mild COPD: a systematic review. Respir Care. 2014 Apr;59(4):588-94. doi: 10.4187/respcare.02742. Epub 2013 Oct 8.
Results Reference
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Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

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