Clinical trial NCT02050711: Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD
Official title: Effects of Pulmonary Rehabilitation on Computerized Respiratory Sounds in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD)
Pulmonary rehabilitation
Computerized respiratory sounds
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2014-01-31
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Change in respiratory sounds
timeFrame: 1 week prior intervention; 1, 12 and 24 weeks post intervention
Secondary outcomes:
measure: Change in lung function
timeFrame: 1 week prior intervention; 1, 12 and 24 weeks post intervention
measure: Change in exercise capacity
timeFrame: 1 week prior intervention; 1, 12 and 24 weeks post intervention
measure: Change in quadriceps muscle strength
timeFrame: 1 week prior intervention; 1, 12 and 24 weeks post intervention
measure: Change in health-related quality of life
timeFrame: 1 week prior intervention; 1, 12 and 24 weeks post intervention
measure: Change in health services use
timeFrame: 1 week prior intervention; 1, 12 and 24 weeks post intervention
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: School of Health Sciences of the University of Aveiro (ESSUA)
name: Alda S Marques, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.