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PEP Buddy in Pulmonary Rehabilitation

A Randomized, Sham Controlled Clinical Trial to Assess the Effectiveness of a Positive End Expiratory Device for Accelerating and Maintaining Pulmonary Rehabilitation Gains

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PEP Buddy, a breathing device, in Veterans with COPD, a long-term lung disease, who are in a lung rehab program. One group will use PEP Buddy, and the other will use a sham device that does not offer the same breathing benefits. The study will check if PEP Buddy helps symptoms and exercise ability improve faster and keeps benefits going longer after rehab ends.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a Veteran.
  • You have been referred to a lung rehab program for COPD.
  • Your FEV1—the amount of air you can blow out in one second—is less than 80% of the expected amount.
  • You can exercise while getting oxygen at 4 liters per minute through small tubes in your nose.

Who can't join

  • The study team thinks a lung disease other than COPD affects your daily shortness of breath.
  • You cannot complete the study steps, or you cannot or do not want to use PEP Buddy.
  • Part of your lung disease is caused by food or liquid entering your lungs, or by nerve or brain conditions that affect your face, mouth, or throat.
  • You are expected to live less than one year.
  • You have a known upcoming surgery that will need a long recovery in the year after you join.
  • You have cancer beyond stage 1 or non-melanoma skin cancer.
  • A memory and thinking test called MoCA shows memory loss.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

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