Device-guided Breathing for Shortness of Breath in COPD

Not Applicable

Completed

• Conditions: COPD; Dyspnea; Hyperinflation

• Registration Number: NCT01286181
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States