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PEP Buddy in Pulmonary Rehabilitation

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-89
SponsorVA Office of Research and Development

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran

Referral to Pulmonary Rehabilitation for COPD

FEV1 <80% predicted

Participants must be able to exercise on 4L/m nasal cannula O2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PEP Buddy

    Device

    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.

  • PEP Buddy Sham

    Device

    A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: PEP BuddyExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

San Diego Shortness of breath Questionnaire

This is a standardized survey used to quantify the impact of daily respiratory symptoms on quality of life. This will be collected on enrollment and the investigators will compare the change between groups at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment.

Time frame
12 Months
2

Daily steps measured by wrist-wron accelerometer

Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study.

Time frame
12 Months

Secondary outcomes

1

One-Minute Sit to Stand test

The investigators will perform this test at enrollment and at weeks 3, 6, 9, and 12 as well as six-and twelve-months after enrollment and compare between groups. This test calculates the number of times a participant can sit and rise from a chair over the course of a minute.

Time frame
12 Months
2

Six Minute Walk Test

A standard test of exercise capacity in those with chronic lung disease. The investigators will assess changes in the six-minute walk test difference from enrollment at Weeks 3, 6, 9, and 12 in the study and at six-and twelve-months after the conclusion of the study.

Time frame
12 months
3

St. George Respiratory Questionaire

The investigators will compare the values between groups from enrollment at Weeks 3, 6, 9, and 12 and at six-and twelve-months after enrollment. This is a standard survey form in which participants report the severity and daily impact of respiratory symptoms and how they may inhibit daily activity.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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