Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02050711
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Alda Sofia Pires de Dias Marques, Aveiro University

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Pulmonary rehabilitation Other: Usual care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Portugal
University of Aveiro
Aveiro, Portugal, 3810-193
Sponsors and Collaborators
Aveiro University
Fundação para a Ciência e a Tecnologia
Investigators
Layout table for investigator information
Principal Investigator: Alda S Marques, PhD School of Health Sciences of the University of Aveiro (ESSUA)
Publications:
Layout table for additonal information
Responsible Party: Alda Sofia Pires de Dias Marques, Senior Lecturer, Aveiro University
ClinicalTrials.gov Identifier: NCT02050711    
Other Study ID Numbers: SFRH/BD/84665/2012
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Alda Sofia Pires de Dias Marques, Aveiro University:
Chronic obstructive pulmonary disease (COPD)
Pulmonary rehabilitation
Computerized respiratory sounds
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Sounds
Respiratory Tract Diseases
Signs and Symptoms, Respiratory