Device-guided Breathing for Shortness of Breath in COPD

NCT01286181 — Not applicable, Completed, 11 participants, Mayo Clinic

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Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2

Registry	NCT01286181
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	11 (Actual)
Sponsor	Mayo Clinic (Other)
Conditions	COPD, Dyspnea, Hyperinflation
Interventions	Twice daily practice of device-guided slow breathing. (Behavioral)
Dates	start 2011-01-01, primary completion 2011-12-01, completion 2011-12-01, first posted 2011-01-31, last updated 2013-04-04
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Device-guided slow breathing	Experimental	Behavioral: Twice daily practice of device-guided slow breathing.

Twice daily practice of device-guided slow breathing. (Behavioral): 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 40 Years to any

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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States

+Investigators

Roberto Benzo, MD, Principal investigator, Mayo Clinic