PEP Buddy in Pulmonary Rehabilitation
Recruiting · NCT07404826 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
PEP BuddyPEP Buddy Sham
What this trial is about
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.
Who can take part
Age range
40 Years to 89 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Cincinnati VA Medical Center, Cincinnati, OH - Cincinnati, Ohio, United States
- Louis Stokes VA Medical Center, Cleveland, OH - Cleveland, Ohio, United States