Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

Study Overview
=================
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.

Official Title
-----------------
Effects of Pulmonary Rehabilitation on Computerized Respiratory Sounds in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Behavioral: Pulmonary rehabilitation
* Other: Usual care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care<br>Patients will receive usual care from their general practitioners/pulmonologists. | Other: Usual care<br> <br> |
| Experimental: Pulmonary rehabilitation<br>Patients will enrol in a 12-week PR program consisting on exercise training (3 times a week) and psychoeducation (once a week). | Behavioral: Pulmonary rehabilitation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week prior intervention; 1, 12 and 24 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function | Lung function will be assessed with a spirometric test, following the American Thoracic Society/European Respiratory Society guidelines. | 1 week prior intervention; 1, 12 and 24 weeks post intervention | 
| Change in exercise capacity | Exercise capacity will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines. | 1 week prior intervention; 1, 12 and 24 weeks post intervention | 
| 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. | 1 week prior intervention; 1, 12 and 24 weeks post intervention | 
| 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. | 1 week prior intervention; 1, 12 and 24 weeks post intervention | 
| Change in health services use | number of visits to casualty; number and duration of hospital admissions. | 1 week prior intervention; 1, 12 and 24 weeks post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive pulmonary disease (COPD), Pulmonary rehabilitation, Computerized respiratory sounds