Device-guided Breathing for Shortness of Breath in COPD

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01286181

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Dyspnea Hyperinflation	Behavioral: Twice daily practice of device-guided slow breathing.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device-guided slow breathing	Behavioral: Twice 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.

Arm

Intervention/Treatment

Experimental: Device-guided slow breathing

Behavioral: Twice 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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