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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Device: PEP Buddy; Device: PEP Buddy Sham

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert M Burkes, MD MS; Phone Number: (724) 730-3862; Email: burkesrt@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220-2213
      • Cincinnati VA Medical Center, Cincinnati, OH
      • Contact: Robert M Burkes, MD MS; Phone Number: (724) 730-3862; Email: burkesrt@ucmail.uc.edu
      • Principal Investigator: Robert Matthew Burkes, MD MS
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Contact: Frank Jacono, MD; Phone Number: 65628 216-791-3800; Email: frank.jacono@va.gov
      • Contact: Anthony Vergis, MD; Phone Number: 65628 2167913800; Email: anthony.vergis@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEP Buddy; This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless	Device: PEP 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.
Sham Comparator: Sham; This 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	Device: PEP 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; Other Names: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-Minute Sit to Stand test	The investigators will perform this test at enrollment and at weeks 3, 6, 9, and 12 as well as six-and twelve-months after enrollment and compare between groups. This test calculates the number of times a participant can sit and rise from a chair over the course of a minute.	12 Months
Six Minute Walk Test	A standard test of exercise capacity in those with chronic lung disease. The investigators will assess changes in the six-minute walk test difference from enrollment at Weeks 3, 6, 9, and 12 in the study and at six-and twelve-months after the conclusion of the study.	12 months
St. George Respiratory Questionaire	The investigators will compare the values between groups from enrollment at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment. This is a standard survey form in which participants report the severity and daily impact of respiratory symptoms and how they may inhibit daily activity.	12 Months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Robert Matthew Burkes, MD MS, Cincinnati VA Medical Center, Cincinnati, OH

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 29, 2030
• Study Completion (Estimated): March 29, 2030

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RRD6-010-24W; 1I01RD000440-01A2 (Other Grant/Funding Number: VA ORD); 25-81 (Other Identifier: VA Central IRB Proposal Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No