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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014