[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486022":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active inspiratory muscle rehabilitation (IMR) group","EXPERIMENTAL","Each participant will be provided a PrO2™ device and trained on its use and its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS\u002FAndroid devices or Mac\u002FWindows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback.\n\nParticipants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal).\n\nThe research team will implement biofeedback signals at a specific inspiratory resistance to provide a precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.",[13],"Device: Pro2 - 60% of participant's MIP",{"label":15,"type":16,"description":17,"interventionNames":18},"SHAM","ACTIVE_COMPARATOR","Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP for each repetition.",[19],"Device: Pro2 - 15% of participant's MIP",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Pro2 - 60% of participant's MIP","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS\u002FAndroid devices or Mac\u002FWindows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Pro2 - 15% of participant's MIP","Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP for each repetition",[15],[32],{"name":33,"affiliation":5,"role":34},"Jason Lang, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Veronica Carrion, BS","CONTACT","9197041523","vmp19@duke.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Jasong Lang, MD","9196843364","jason.lang@duke.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Duke Healthy Lifestyles Clinic","RECRUITING","Durham","North Carolina","27704","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-78.89862,35.99403,{"lat":58,"lon":57},[61],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65],{"name":66,"class":6},"American Lung Association","100486022","inspiratory-pulmonary-rehabilitation-for-children-with-obesity-and-asthma-100486022",false,"NCT05608668","Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma","iPro","Inclusion Criteria:\n\n* Documented informed consent from legal guardian and assent from participant as appropriate.\n* Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma.\n* Participants (or parent\u002Fguardian) must have access to the internet and an approved smart device\u002Fcomputer.\n* Child must have a designated caregiver who expresses a commitment to encourage the participant to complete the study procedures.\n* Participant and legal guardian must speak and read English.\n* Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)\n\nExclusion Criteria:\n\n* Prior intubation for asthma\n* Current self-reported pregnancy or planning to become pregnant.\n* Have an FEV1 \\\u003C 50% of predicted at screening\n* History of lung surgery in the past two years,\n* History of pulmonary embolism in the past two years,\n* Any history of recurrent spontaneous pneumothorax, or pneumothorax in the past 12 months\n* Current undiagnosed chest pain,\n* History of inner ear surgery in the past 12 months,\n* Undiagnosed syncopal episodes in the past two years,\n* Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.\n* Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment.\n* Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms","ALL","8 Years","17 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma.\n\nClinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity",[85,86],"Pediatric Obesity","Pediatric Asthma",[88,89,90],"Asthma","Obesity","Pediatric","2025-08-18",{"date":93,"type":94},"2025-08-22","ACTUAL",{"date":96,"type":94},"2023-07-27",{"date":98,"type":79},"2026-06",{"name":5,"class":6},1]