PEP Buddy in Pulmonary Rehabilitation
PEPR
A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
3 other identifiers
interventional
120
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2030
February 17, 2026
February 1, 2026
4 years
February 4, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
San Diego Shortness of breath Questionnaire
This is a standardized survey used to quantify the impact of daily respiratory symptoms on quality of life. This will be collected on enrollment and the investigators will compare the change between groups at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment.
12 Months
Daily steps measured by wrist-wron accelerometer
Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.
12 Months
Secondary Outcomes (3)
One-Minute Sit to Stand test
12 Months
Six Minute Walk Test
12 months
St. George Respiratory Questionaire
12 Months
Study Arms (2)
PEP Buddy
EXPERIMENTALThis arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless
Sham
SHAM COMPARATORThis arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless
Interventions
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.
A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing
Eligibility Criteria
You may qualify if:
- Veteran
- Referral to Pulmonary Rehabilitation for COPD
- FEV1 \<80% predicted
- Participants must be able to exercise on 4L/m nasal cannula O2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213, United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Matthew Burkes, MD MS
Cincinnati VA Medical Center, Cincinnati, OH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Both participants and research team will be blinded. Participants will be provided with a device in an opaque box, both PEP Buddy and sham packaging will be the same. The dives themselves will look similar and the difference between PEP Buddy and sham will not be able to be determined by the naked eye.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 12, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
March 29, 2030
Study Completion (Estimated)
March 29, 2030
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data will not be shared until the close of the study (March 2025). The investigators will then share data for six years after close of study.
- Access Criteria
- The investigators ask that any requesting entity contact the Primary Investigator by e-mail to begin a request for data via VA processes.
The investigators will share data with VA researchers that will be de-identified via Safe Harbor approach. However, if a non-VA researcher requests aggregate data, the investigators will work with local research office, facility privacy officer, and information security officer to identify an applicable agreement for data sharing. No VA data will include any PHI to any non-VA researchers requesting VA data.