Device-guided Breathing for Shortness of Breath in COPD

NCT01286181 | Completed

• 1 other identifier: 10-008433
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Dyspnea; Hyperinflation

Keywords

COPD; Biofeedback; Dyspnea; Quality of life; Stress

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Evaluate effect of device-guided slow breathing on daily physical activity.

  8 weeks

Study Arms (1)

Device-guided slow breathing

EXPERIMENTAL

Behavioral: Twice daily practice of device-guided slow breathing.

Interventions

Twice daily practice of device-guided slow breathing. BEHAVIORAL

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.

Device-guided slow breathing

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Roberto Benzo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)