PEP Buddy in Pulmonary Rehabilitation (PEPR)

VA Office of Research and Development

Status: Not yet enrolling

Conditions: COPD

Treatments: Device: PEP Buddy Sham; Device: PEP Buddy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07404826

25-81 (Other Identifier)

1I01RD000440-01A2 (Other Grant/Funding Number)

RRD6-010-24W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

PEP Buddy

Experimental group

Description:

This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless

Treatment:

Device: PEP Buddy

Sham

Sham Comparator group

Description:

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

Treatment:

Device: PEP Buddy Sham