[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07404826":3,"trial-entities:NCT07404826":125,"trial-summary:NCT07404826":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":49,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":79,"locations":82,"central_contacts":119,"overall_officials":121,"references":123,"see_also_links":124},"NCT07404826","RRD6-010-24W","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","RECRUITING","2030-07-29","2026-07","2026-07-24","2026-07-16","VA Office of Research and Development","FED",true,"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.",[19],"COPD",[21],"Pulmonary Rehabilitation","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},120,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","PEP 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.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"PEP 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",[39],"Sham",[39],[42,46],{"measure":43,"description":44,"timeFrame":45},"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",{"measure":47,"description":48,"timeFrame":45},"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.",[50,53,57],{"measure":51,"description":52,"timeFrame":45},"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.",{"measure":54,"description":55,"timeFrame":56},"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",{"measure":58,"description":59,"timeFrame":45},"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.","ALL","40 Years","89 Years",false,{"inclusion":65,"exclusion":70,"raw_text":78},[66,67,68,69],"Veteran","Referral to Pulmonary Rehabilitation for COPD","FEV1 \\\u003C80% predicted","Participants must be able to exercise on 4L\u002Fm nasal cannula O2",[71,72,73,74,75,76,77],"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 \\\u003C1 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","Inclusion Criteria:\n\n* Veteran\n* Referral to Pulmonary Rehabilitation for COPD\n* FEV1 \\\u003C80% predicted\n* Participants must be able to exercise on 4L\u002Fm nasal cannula O2\n\nExclusion Criteria:\n\n* Those deemed by the study personnel to have a lung disease other than COPD impacting their daily dyspnea\n* Those that are unable to perform study procedures or are unwilling or unable to use PEP Buddy\n* Those that have a component of lung disease driven by aspiration or neurological conditions affecting the face or oropharynx\n* Those with a life expectancy of \\\u003C1 year\n* Those with a known surgical intervention that will require a prolonged recovery in the year after enrollment\n* Those with a malignancy beyond Stage I or non-melanoma skin cancer\n* Those shown shown to have memory loss of MOCA testing",[80,81],"ADULT","OLDER_ADULT",[83,101],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"Cincinnati VA Medical Center, Cincinnati, OH","Cincinnati","Ohio","45220-2213","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Robert M Burkes, MD MS","CONTACT","(724) 730-3862","robert.burkes@va.gov",{"name":96,"role":97},"Robert Matthew Burkes, MD MS","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},39.12711,-84.51439,{"facility":102,"status":103,"city":104,"state":86,"zip":105,"country":88,"contacts":106,"geoPoint":116},"Louis Stokes VA Medical Center, Cleveland, OH","NOT_YET_RECRUITING","Cleveland","44106-1702",[107,112],{"name":108,"role":92,"phone":109,"phoneExt":110,"email":111},"Frank Jacono, MD","216-791-3800","65628","frank.jacono@va.gov",{"name":113,"role":92,"phone":114,"phoneExt":110,"email":115},"Anthony Vergis, MD","2167913800","anthony.vergis@va.gov",{"lat":117,"lon":118},41.4995,-81.69541,[120],{"name":91,"role":92,"phone":93,"email":94},[122],{"name":96,"affiliation":84,"role":97},[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Chronic Obstructive Pulmonary Disease",[],{"nct_id":4,"found":15,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is a randomized, double-blinded, sham-controlled study involving 120 participants. You would be randomly assigned to receive either the PEP Buddy device or a sham device, and neither you nor the study staff would know which one you received.","completed","PEP Buddy in Pulmonary Rehabilitation for COPD","This study is testing a device called PEP Buddy for Veterans with Chronic Obstructive Pulmonary Disease (COPD). PEP Buddy is a small, portable device worn around the neck that may help control shortness of breath. You would be randomly assigned to receive either the actual PEP Buddy or a \"sham\" device that looks the same but only provides the breathing support of standard pursed-lip breathing. Researchers want to see if PEP Buddy helps improve symptoms and exercise ability faster during and after pulmonary rehabilitation. To join, you need to be a Veteran with COPD, aged 40-89, able to exercise on 4 liters per minute of oxygen, and have an FEV1 (a measure of lung function) less than 80% of what's expected. The study aims to enroll 120 participants and will measure improvements in shortness of breath and daily steps over 12 months.","Your shortness of breath and daily steps will be measured for 12 months.",142,"You would participate in pulmonary rehabilitation and use the assigned device. Your shortness of breath and daily steps would be measured over 12 months.","Not stated in the trial record.",[32],"v2"]