[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647198":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":25},{"fullName":5,"class":6},"Changhua Christian Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS)","EXPERIMENTAL","Participants will perform diaphragmatic breathing exercises assisted by a volume-oriented incentive spirometer twice daily for 20 minutes per session over a 4-week intervention period under standardized instructions.",[13],"Behavioral: Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.",[19],"Behavioral: standard pharmacological treatment with lifestyle modification education",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"standard pharmacological treatment with lifestyle modification education",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Shu-Ju Tu, NP, PHD Candidate","CONTACT","+88647238595","7591","79610@cch.orh.tw",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Kun-Ching Chou","MD","100647198","volume-oriented-incentive-spirometry-assisted-diaphragmatic-breathing-exercise-for-functional-heartburn-or-reflux-hypersensitivity-100647198",false,"NCT07706101","Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity","Effect of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise in Patients With Functional Heartburn or Reflux Hypersensitivity: A Pilot Randomized Controlled Trial","VISDBE","* Inclusion Criteria:\n\n  * Adults aged 20 to 100 years.\n  * Diagnosis of functional heartburn (FH) or reflux hypersensitivity (RH) according to the Rome IV criteria.\n  * Normal upper gastrointestinal endoscopy without evidence of erosive esophagitis, Barrett's esophagus, or hiatal hernia.\n  * Normal esophageal motility on high-resolution manometry (HRM) according to the Chicago Classification Version 4.0.\n  * Diagnosis of FH or RH confirmed by 24-hour multichannel intraluminal impedance-pH (MII-pH) monitoring according to the Rome IV criteria and Lyon Consensus 2.0.\n  * Able and willing to perform diaphragmatic breathing exercises and comply with study procedures.\n  * Able to provide written informed consent.\n* Exclusion Criteria:\n\n  * Pregnant or breastfeeding women.\n  * Severe cardiopulmonary dysfunction or chronic respiratory disease.\n  * Inability to perform diaphragmatic breathing exercises or comply with the study protocol and scheduled follow-up visits","ALL","20 Years","100 Years",{"count":52,"type":53},82,"ESTIMATED","INTERVENTIONAL",[56],"NA","The goal of this pilot randomized controlled trial is to determine whether volume-oriented incentive spirometry-assisted diaphragmatic breathing exercise (VIS-assisted DBE) can improve reflux-related symptoms and health-related quality of life in adults with functional heartburn (FH) or reflux hypersensitivity (RH).\n\nThe main questions it aims to answer are:\n\nDoes VIS-assisted DBE reduce reflux-related symptoms compared with usual care? Does VIS-assisted DBE improve health-related quality of life compared with usual care? Researchers will compare VIS-assisted DBE plus usual care with usual care alone to determine whether the intervention provides additional benefits in symptom relief and quality of life.\n\nParticipants will:\n\nComplete baseline clinical evaluations and symptom questionnaires. Be randomly assigned to either the VIS-assisted DBE group or the usual care group.\n\nReceive either VIS-assisted diaphragmatic breathing exercises twice daily for 20 minutes over a 4-week period in addition to usual care, or usual care alone.\n\nComplete follow-up assessments after the 4-week intervention, including symptom and quality-of-life questionnaires",[59,60],"Functional Heartburn (FH)","Reflux Hypersensitivity",[62,60,63,64,65,66,67],"Functional Heartburn","Volume-Oriented Incentive Spirometry","Diaphragmatic Breathing Exercise","Disorders of Gut-Brain Interaction","Autonomic Nervous System","Quality of Life","NOT_YET_RECRUITING","2026-07-10",{"date":71,"type":72},"2026-07-15","ACTUAL",{"date":74,"type":53},"2026-08-20",{"date":76,"type":53},"2028-07-30",{"name":5,"class":6}]