A randomized, sham controlled clinical trial to assess the effectiveness of a positive end expiratory device for accelerating and maintaining pulmonary rehabilitation gains

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating condition with a higher prevalence among Veterans compared to the general population. Pulmonary rehabilitation (PR) represents the most effective non- pharmaceutical treatment option for control of daily symptoms and promoting functional independence. Successful completion of PR is roundly thought to improve quality of life. While the benefits of PR are well documented, there is a critical need to improve PR outcomes, accelerate response to PR, and maintain gains made in programs. In this randomized controlled trial, we will test the impact of a portable, user-friendly positive expiratory pressure device (PEP Buddy) as an additional tool used in PR vs. sham. This study investigates outcomes in both the active PR setting and post discharge. In preliminary studies, PEP Buddy has been shown to improve symptoms and quality-of-life scores, improve walk distance, and enhance physiological response to exercise after a brief time in persons with COPD and excessive dynamic airways collapse. Based on promising preliminary data, we propose investigation of outcomes over the course of PR and post-discharge to define the utility of PEP Buddy as an integral tool for COPD patients. Further, we find it necessary to fully define the effect of PEP Buddy on respiratory mechanics during exercise and have developed an aim using modified graded cycle ergometry that will thoroughly define the differential exercise physiology when the PEP Buddy is being used vs not by employing a cross-over study. As stated above, the main benefits of PR fall into a multitude of domains including psychological, functional, and physiological which we will investigate separately in this trial. The trial will run for four years, in the first three years we will recruit at least 120 new enrollees to PR with COPD, block randomized into equally-sized, double-blinded cohorts of PEP Buddy vs. sham. Our center actively enrolled ~140 COPD participants in pulmonary rehabilitation in Fiscal Year 2021 among ~220 referrals, with increases in 2022 and 2023, respectively. Outcomes will be collected at enrollment, every three weeks up to discharge, and at the six- and 12-month time periods after enrollment (e.g., post-discharge outcomes). In AIM 1a, we will compare total and rate of improvements in validated psychological and quality-of-life questionnaires between groups at each time point. We hypothesize that those in the PEP Buddy arm will show greater improvements earlier in their PR course and maintain the gains made in PR after discharge. AIM 1b assesses the results of actigraphy monitoring, walk distance, sit-to-stand testing, and other metrics of functional status in PEP Buddy vs. sham. Similar to quality-of-life and psychological scores, we expect improvements to be seen early in the PR course and be greater over the course of PR and after discharge. Our rationale for these hypotheses is that PEP Buddy will provide a readily accessible tool to overcome the symptoms of dynamic hyperinflation, assist in breathing control, and allow PR participants to recover more quickly and thoroughly from exercise-induced symptoms when compared to those learning the standard techniques in PR. In AIM 2, we will select 30 participants from Aim 1a/b and perform a crossover study utilizing graded cycle ergometry and dynamic tidal volume measurements to define the differences in the physiologic response to exercise when using the PEP Buddy device and when not. This will define the mechanism by which PEP Buddy is effective in preventing dynamic hyperinflation and increasing work output in those with COPD. At the conclusion of this study, we will have identified a user-friendly device that can be readily implemented into any PR program that promotes self-efficacy, directly enhances the response to PR, and leads to maintained PR gains. As the availability of PR expands, we are hopeful that fully elucidating the benefits of tools such as P Project Number: 1I01RD000440-01A2 | Fiscal Year: 2026 | NIH Institute/Center: Veterans Affairs (VA) | Principal Investigator: Robert Burkes (+1 co-PI) | Institution: CINCINNATI VA MEDICAL CENTER RESEARCH, CINCINNATI, OH | Activity Code: I01 | Study Section: Chronic Medical Conditions & Aging[RRD6] View on NIH RePORTER: https://reporter.nih.gov/project-details/11242137