PEP Buddy in Pulmonary Rehabilitation

Purpose

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.

Condition

  • COPD

Eligibility

Eligible Ages
Between 40 Years and 89 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be block randomized in groups of varying sizes to either PEP Buddy or sham. The PEP Buddy and sham groups will run in parallel.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Both participants and research team will be blinded. Participants will be provided with a device in an opaque box, both PEP Buddy and sham packaging will be the same. The dives themselves will look similar and the difference between PEP Buddy and sham will not be able to be determined by the naked eye.

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Device: PEP Buddy
    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.
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
  • Device: PEP Buddy Sham
    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

Recruiting Locations

Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio 45220-2213
Contact:
Robert M Burkes, MD MS
(724) 730-3862
robert.burkes@va.gov

More Details

Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Robert M Burkes, MD MS
(724) 730-3862
robert.burkes@va.gov

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.