Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-01

Study Completion Date

2013-09-30

Brief Summary

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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.

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COMPLETED PHASE1

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Usual care

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

Group Type OTHER

Usual care

Intervention Type OTHER

Pulmonary rehabilitation

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

Group Type EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type BEHAVIORAL

Interventions

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Pulmonary rehabilitation

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No