Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07404826

PEP Buddy in Pulmonary Rehabilitation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP Buddy

Device

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.

PEP Buddy Sham

Device

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

Primary outcomes

  1. San Diego Shortness of breath Questionnaire

    Time frame: 12 Months

    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.

  2. Daily steps measured by wrist-wron accelerometer

    Time frame: 12 Months

    Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.

Secondary outcomes

  1. One-Minute Sit to Stand test

    Time frame: 12 Months

    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.

  2. Six Minute Walk Test

    Time frame: 12 months

    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.

  3. St. George Respiratory Questionaire

    Time frame: 12 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert M Burkes, MD MS

CONTACT

[email protected]

(724) 730-3862

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains

Acronym: PEPR

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 12, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.