[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624068":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":79,"collaborators":25,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Device: PEP Buddy",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Device: PEP Buddy Sham",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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",[15],[15],[32],{"name":33,"affiliation":34,"role":35},"Robert Matthew Burkes, MD MS","Cincinnati VA Medical Center, Cincinnati, OH","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Robert M Burkes, MD MS","CONTACT","(724) 730-3862","robert.burkes@va.gov",[43,59],{"facility":34,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Cincinnati","Ohio","45220-2213","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-84.51439,39.12711,{"lat":54,"lon":53},[57,58],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},{"name":33,"role":35,"phone":25,"phoneExt":25,"email":25},{"facility":60,"status":61,"city":62,"state":46,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Louis Stokes VA Medical Center, Cleveland, OH","NOT_YET_RECRUITING","Cleveland","44106-1702",{"type":51,"coordinates":65},[66,67],-81.69541,41.4995,{"lat":67,"lon":66},[70,75],{"name":71,"role":39,"phone":72,"phoneExt":73,"email":74},"Frank Jacono, MD","216-791-3800","65628","frank.jacono@va.gov",{"name":76,"role":39,"phone":77,"phoneExt":73,"email":78},"Anthony Vergis, MD","2167913800","anthony.vergis@va.gov",{"type":80,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624068","pep-buddy-in-pulmonary-rehabilitation-100624068",false,"NCT07404826","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","PEPR","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","ALL","40 Years","89 Years",{"count":93,"type":94},120,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.",[100],"COPD",[102],"Pulmonary Rehabilitation","2026-07-23",{"date":105,"type":106},"2026-07-24","ACTUAL",{"date":108,"type":106},"2026-07-16",{"date":110,"type":94},"2030-07-29",{"name":5,"class":6},2]