Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050711
• Other study ID #: SFRH/BD/84665/2012
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: January 18, 2018
• Start date: September 1, 2009
• Est. completion date: September 30, 2013

Study information

• Verified date: January 2018
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 30, 2013
• Est. primary completion date: March 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Sounds

Intervention

Behavioral:
• Pulmonary rehabilitation

Other:
• Usual care

Locations

Country	Name	City	State
Portugal	University of Aveiro	Aveiro

Sponsors (2)

Lead Sponsor	Collaborator
Aveiro University	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (2)

Jácome C, Marques A. Pulmonary rehabilitation for mild COPD: a systematic review. Respir Care. 2014 Apr;59(4):588-94. doi: 10.4187/respcare.02742. Epub 2013 Oct 8. Review. — View Citation

Marques A, Oliveira A, Jácome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17. Review. Erratum in: Respir Care. 2016 Jan;61(1):e1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in respiratory sounds	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	Change in lung function	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
Secondary	Change in exercise capacity	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
Secondary	Change in quadriceps muscle strength	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
Secondary	Change in health-related quality of life	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
Secondary	Change in health services use	number of visits to casualty; number and duration of hospital admissions.	1 week prior intervention; 1, 12 and 24 weeks post intervention