Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT02050711|
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Behavioral: Pulmonary rehabilitation Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Pulmonary Rehabilitation on Computerized Respiratory Sounds in Patients With Chronic Obstructive Pulmonary Disease|
|Actual Study Start Date :||September 1, 2009|
|Actual Primary Completion Date :||March 20, 2013|
|Actual Study Completion Date :||September 30, 2013|
Patients will receive usual care from their general practitioners/pulmonologists.
Other: Usual care
Experimental: Pulmonary rehabilitation
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
- Change in respiratory sounds [ Time Frame: 1 week prior intervention; 1, 12 and 24 weeks post intervention ]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.
- Change in lung function [ Time Frame: 1 week prior intervention; 1, 12 and 24 weeks post intervention ]Lung function will be assessed with a spirometric test, following the American Thoracic Society/European Respiratory Society guidelines.
- Change in exercise capacity [ Time Frame: 1 week prior intervention; 1, 12 and 24 weeks post intervention ]Exercise capacity will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines.
- Change in quadriceps muscle strength [ Time Frame: 1 week prior intervention; 1, 12 and 24 weeks post intervention ]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 [ Time Frame: 1 week prior intervention; 1, 12 and 24 weeks post intervention ]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 [ Time Frame: 1 week prior intervention; 1, 12 and 24 weeks post intervention ]number of visits to casualty; number and duration of hospital admissions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050711
|University of Aveiro|
|Aveiro, Portugal, 3810-193|
|Principal Investigator:||Alda S Marques, PhD||School of Health Sciences of the University of Aveiro (ESSUA)|