Effects of Pulmonary Rehabilitation on Computerized Respiratory Sounds in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Change in respiratory sounds
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Usual care
Patients will receive usual care from their general practitioners/pulmonologists.
Intervention: Usual care (Other)
Pulmonary rehabilitation
Patients will enrol in a 12-week PR program consisting on exercise training (3 times a week) and psychoeducation (once a week).
Intervention: Pulmonary rehabilitation (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Alda Sofia Pires de Dias Marques
Senior Lecturer
Aveiro University