Skip to main content
Clinical Trials/NCT02050711
NCT02050711
Completed
N/A

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

Aveiro University1 site in 1 country106 target enrollmentSeptember 1, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Aveiro University
Enrollment
106
Locations
1
Primary Endpoint
Change in respiratory sounds
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2009
End Date
September 30, 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Aveiro University
Responsible Party
Principal Investigator
Principal Investigator

Alda Sofia Pires de Dias Marques

Senior Lecturer

Aveiro University

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in lung function(1 week prior intervention; 1, 12 and 24 weeks post intervention)
  • Change in exercise capacity(1 week prior intervention; 1, 12 and 24 weeks post intervention)
  • Change in quadriceps muscle strength(1 week prior intervention; 1, 12 and 24 weeks post intervention)
  • Change in health-related quality of life(1 week prior intervention; 1, 12 and 24 weeks post intervention)
  • Change in health services use(1 week prior intervention; 1, 12 and 24 weeks post intervention)

Study Sites (1)

Loading locations...

Similar Trials