Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Mayo Clinic
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Determine effect of increased device-guided breathing on health-related quality of life measures.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided breathing is a behavioral intervention that guides respiratory rates into a therapeutic range; prolongation of the expiratory phase improves hyperinflation, the most significant driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.
Investigators
Roberto P. Benzo
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Current or former cigarette smokers of at least 10 pack-years
- •Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of \> 150% predicted or an FEV1 of \<65% predicted
- •Clinical diagnosis of chronic obstructive pulmonary disease
Exclusion Criteria
- •Unable to use the slow-breathing device due to hearing impairment
- •Poor motivation or lack of interest in using the device
- •Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment
Outcomes
Primary Outcomes
Determine effect of increased device-guided breathing on health-related quality of life measures.
Time Frame: 8 weeks
Pre and post device use measures of dyspnea, health-related quality of life, stress, adn self-efficacy for managing chronic disease will be obtained through self-administered questionnaires.
Secondary Outcomes
- Evaluate effect of device-guided slow breathing on daily physical activity.(8 weeks)