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NCT Number: NCT02050711

Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aveiro

Aveiro, 3810-193, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary rehabilitation

Behavioral

Usual Care

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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