COPD
Conditions
Keywords
Pulmonary Rehabilitation
Brief summary
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
DEVICEPEP 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.
DEVICEPEP 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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both participants and research team will be blinded. Participants will be provided with a device in an opaque box, both PEP Buddy and sham packaging will be the same. The dives themselves will look similar and the difference between PEP Buddy and sham will not be able to be determined by the naked eye.
Intervention model description
Participants will be block randomized in groups of varying sizes to either PEP Buddy or sham. The PEP Buddy and sham groups will run in parallel.
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| San Diego Shortness of breath Questionnaire | 12 Months | 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. |
| Daily steps measured by wrist-wron accelerometer | 12 Months | Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| One-Minute Sit to Stand test | 12 Months | 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. |
| Six Minute Walk Test | 12 months | 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. |
| St. George Respiratory Questionaire | 12 Months | 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. |
Countries
United States
Contacts
CONTACTRobert M Burkes, MD MS
PRINCIPAL_INVESTIGATORRobert Matthew Burkes, MD MS
Cincinnati VA Medical Center, Cincinnati, OH
Outcome results
None listed