A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
VA Office of Research and Development
Summary
In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.
Description
In this randomized, double-blinded, sham-controlled clinical trial, the investigators will test the effectiveness of the use of a positive expiratory device (PEP Buddy) vs. sham in participants with COPD in Pulmonary Rehabilitation and after discharge from Pulmonary Rehabilitation for up to one year. The investigators will compare changes in quality of life metrics and measurements of functional capacity between the intervention and sham groups over the course of the study.
Eligibility
- Age range
- 40–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Veteran * Referral to Pulmonary Rehabilitation for COPD * FEV1 \<80% predicted * Participants must be able to exercise on 4L/m nasal cannula O2 Exclusion Criteria: * Those deemed by the study personnel to have a lung disease other than COPD impacting their daily dyspnea * Those that are unable to perform study procedures or are unwilling or unable to use PEP Buddy * Those that have a component of lung disease driven by aspiration or neurological conditions affecting the face or oropharynx * Those with a life expectancy of \<1 year * Those with a known surgical interven…
Interventions
- DevicePEP Buddy
This is a small, portable device worn about the neck with a lanyard, that can be used to control symptoms of breathlessness associated with chronic lung disease.
- DevicePEP Buddy Sham
A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing
Locations (2)
- Cincinnati VA Medical Center, Cincinnati, OHCincinnati, Ohio
- Louis Stokes VA Medical Center, Cleveland, OHCleveland, Ohio