PEP Buddy in Pulmonary Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEP Buddy, PEP Buddy Sham.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: 40 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains
Overview
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.
Interventions
- 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. - 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
Primary outcome measures
- San Diego Shortness of breath Questionnaire [Time frame: 12 Months]
- Daily steps measured by wrist-wron accelerometer [Time frame: 12 Months]
Secondary outcome measures (3)
- One-Minute Sit to Stand test [Time frame: 12 Months]
- Six Minute Walk Test [Time frame: 12 months]
- St. George Respiratory Questionaire [Time frame: 12 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Identifiers
NCT: NCT07404826 · RRD6-010-24W · 1I01RD000440-01A2 · 25-81