Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

NCT02050711 | Completed

• 1 other identifier: SFRH/BD/84665/2012
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease (COPD); Pulmonary rehabilitation; Computerized respiratory sounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Arms (2)

Usual care

OTHER

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

Other: Usual care

Pulmonary rehabilitation

EXPERIMENTAL

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

Interventions

Pulmonary rehabilitation BEHAVIORAL

Pulmonary rehabilitation

Usual care OTHER

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of concomitant respiratory diseases;
• presence of severe psychiatric conditions;
• presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Related Publications (2)

• Marques A, Oliveira A, Jacome 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.

  PMID: 24046460 BACKGROUND

• Jacome 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.

  PMID: 24106321 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alda S Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 31, 2014
• Study Start: September 1, 2009
• Primary Completion: March 20, 2013
• Study Completion: September 30, 2013
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

PT (1)