Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

January 18, 2018 updated by: Alda Sofia Pires de Dias Marques, Aveiro University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Aveiro, Portugal, 3810-193
        • University of Aveiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual care
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveiro University

Collaborators

Fundação para a Ciência e a Tecnologia

Investigators

  • Principal Investigator: Alda S Marques, PhD, School of Health Sciences of the University of Aveiro (ESSUA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

March 20, 2013

Study Completion (Actual)

September 30, 2013

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFRH/BD/84665/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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