Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RD000440-01A2 | U.S. NIH Grant/Contract | View source | |
| 25-81 | Other Identifier | VA Central IRB Proposal Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP Buddy | Experimental | This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless |
|
| Sham | Sham Comparator | This arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP Buddy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| San Diego Shortness of breath Questionnaire | 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. | 12 Months |
| Daily steps measured by wrist-wron accelerometer | Using accelerometry, the investigators will show the changes in daily step counts between groups over the one year of time in the study. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| One-Minute Sit to Stand test | 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. | 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert M Burkes, MD MS | Contact | (724) 730-3862 | burkesrt@ucmail.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Matthew Burkes, MD MS | Cincinnati VA Medical Center, Cincinnati, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220-2213 | United States |
The investigators will share data with VA researchers that will be de-identified via Safe Harbor approach. However, if a non-VA researcher requests aggregate data, the investigators will work with local research office, facility privacy officer, and information security officer to identify an applicable agreement for data sharing. No VA data will include any PHI to any non-VA researchers requesting VA data.
Data will not be shared until the close of the study (March 2025). The investigators will then share data for six years after close of study.
The investigators ask that any requesting entity contact the Primary Investigator by e-mail to begin a request for data via VA processes.
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
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.
Not provided
Not provided
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.
| PEP Buddy Sham | Device | A Device that appears the same as PEP Buddy but only provides the expiratory pressure of the standard-of-care pursed lip breathing |
|
|
| Six Minute Walk Test |
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. |
| 12 months |
| St. George Respiratory Questionaire | 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. | 12 Months |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |