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Device-guided Breathing for Shortness of Breath in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01286181
First received: January 26, 2011
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
COPD
Dyspnea
Hyperinflation
 Behavioral: Twice daily practice of device-guided slow breathing.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Determine effect of increased device-guided breathing on health-related quality of life measures. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286181

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Roberto Benzo, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01286181     History of Changes
Other Study ID Numbers: 10-008433
Study First Received: January 26, 2011
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
COPD
Biofeedback
Dyspnea
Quality of life
Stress

Additional relevant MeSH terms:
Dyspnea
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases, Obstructive
Lung Diseases

ClinicalTrials.gov processed this record on May 23, 2013