NCT07404826NARecruiting

PEP Buddy in Pulmonary Rehabilitation

VA Office of Research and Development

Start Date

7/16/2026

Completion Date

7/29/2030

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.

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.

Eligibility Criteria

Age Range: 40 years to 89 years

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

Interventions

DEVICE

PEP Buddy

DEVICE

PEP Buddy Sham

Interested in This Trial?

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Conditions

COPD

Locations

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