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PEP Buddy in Pulmonary Rehabilitation

PEP Buddy in Pulmonary Rehabilitation

Recruiting
40-89 years
All
Phase N/A

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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.

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.

Eligibility

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 details
    COPD

NCT07404826

VA Office of Research and Development

25 July 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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