Back to resultsDevice-guided Breathing for Shortness of Breath in COPD
Primary Purpose
COPD, Dyspnea, Hyperinflation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Twice daily practice of device-guided slow breathing.
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Biofeedback, Dyspnea, Quality of life, Stress
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device-guided slow breathing
Arm Description
Outcomes
Primary Outcome Measures
Determine effect of increased device-guided breathing on health-related quality of life measures.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01286181
Brief Title
Device-guided Breathing for Shortness of Breath in COPD
Official Title
Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Dyspnea, Hyperinflation
Keywords
COPD, Biofeedback, Dyspnea, Quality of life, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device-guided slow breathing
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Twice daily practice of device-guided slow breathing.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine effect of increased device-guided breathing on health-related quality of life measures.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Evaluate effect of device-guided slow breathing on daily physical activity.
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Benzo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Device-guided Breathing for Shortness of Breath in COPD
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