COPD, Dyspnea, Hyperinflation
Conditions
Keywords
COPD, Biofeedback, Dyspnea, Quality of life, Stress
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.
Interventions
BEHAVIORALTwice daily practice of device-guided slow breathing.
Participants are asked to use the slow-breathing device for 20 minutes twice daily, for 8 weeks. Participants receive weekly telephone calls to monitor device use and are encouraged to use pursed-lips when following the breathing tones of the device while exhaling.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine effect of increased device-guided breathing on health-related quality of life measures. | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate effect of device-guided slow breathing on daily physical activity. | 8 weeks | Evaluate the effect of a higher intensity of device-guided breathing (20 minutes twice daily for 8 weeks) on daily physical activity, as measured by a gold-standard activity monitor, before and after device use. |
Countries
United States
Outcome results
None listed