A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 89
Healthy Volunteers: f
View:
• Veteran
• Referral to Pulmonary Rehabilitation for COPD
• FEV1 \<80% predicted
• Participants must be able to exercise on 4L/m nasal cannula O2
Locations
United States
Ohio
Cincinnati VA Medical Center, Cincinnati, OH
RECRUITING
Cincinnati
Louis Stokes VA Medical Center, Cleveland, OH
NOT_YET_RECRUITING
Cleveland
Contact Information
Primary
Robert M Burkes, MD MS
robert.burkes@va.gov
(724) 730-3862
Time Frame
Start Date: 2026-07-16
Estimated Completion Date: 2030-07-29
Participants
Target number of participants: 120
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development