PEP Buddy in Pulmonary Rehabilitation
A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
Who can join
Ages 40 to 89 · All sexes
Full eligibility criteria
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 intervention that will require a prolonged recovery in the year after enrollment * Those with a malignancy beyond Stage I or non-melanoma skin cancer * Those shown shown to have memory loss of MOCA testing
About the study
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.
What is being tested
- PEP Buddy (device)
- PEP Buddy Sham (device)
Sponsor: VA Office of Research and Development · Participants: 120 · Started: Jul 16, 2026
Contact the study team
- Robert M Burkes, MD MS · Phone: (724) 730-3862
Official record on ClinicalTrials.gov — NCT07404826
Locations in the U.S.
| Ohio | Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati Louis Stokes VA Medical Center, Cleveland, OH, Cleveland (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.