[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640927":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":48,"overallOfficials":58,"centralContacts":63,"locations":72,"responsibleParty":91,"collaborators":23,"id":94,"slug":23,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":23,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":23,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":23,"overallStatus":112,"whyStopped":23,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Izmir University of Economics","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Symptom Severity","The Reflux Disease Questionnaire (RDQ) will be used to measure the severity of clinical symptoms. The RDQ is a 12-item self-report scale that assesses the frequency and severity of upper gastrointestinal symptoms over the past week. Each item is rated on a Likert scale from 0 to 5, and the total score is calculated as the average of the relevant items. A higher score indicates more severe symptoms.","4 weeks",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Inspiratory Muscle Strength","The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).",{"measure":18,"description":19,"timeFrame":12},"Gastroesophageal Reflux Disease-Related Quality of Life","The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) will be used. The questionnaire will be evaluated based on the total score, with a higher score indicating poorer quality of life.",{"measure":21,"description":22,"timeFrame":12},"Change in Diagnostic Symptom Score","The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) will be used to assess changes in diagnostic symptom scores. A high score indicates severe symptoms.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.","TREATMENT",{"masking":30,"maskingDescription":23,"whoMasked":31},"DOUBLE",[32,33],"INVESTIGATOR","OUTCOMES_ASSESSOR","The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days\u002Fweek, for 4 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 4 weeks of training.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Study Group","EXPERIMENTAL","Patients who will perform inspiratory muscle training (IMT) with %60 loading",[41],"Device: Inspiratory Muscle Training (IMT)",{"label":43,"type":44,"description":45,"interventionNames":46},"Sham Group","SHAM_COMPARATOR","Patients who will perform Sham IMT",[47],"Device: Sham IMT",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"DEVICE","Inspiratory Muscle Training (IMT)","The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure, measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.",[37],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":23},"Sham IMT","The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.",[43],[59],{"name":60,"affiliation":61,"role":62},"Rıdvan Aktan, Assoc Prof.","İzmir University of Economics","PRINCIPAL_INVESTIGATOR",[64,68],{"name":60,"role":65,"phone":66,"phoneExt":23,"email":67},"CONTACT","+905453318172","ridvanaktan@gmail.com",{"name":69,"role":65,"phone":70,"phoneExt":23,"email":71},"Nilay Danış, Assoc Prof.","+90 2324123704","nilaydanis17@gmail.com",[73],{"facility":5,"status":23,"city":74,"state":75,"zip":76,"country":77,"countryCode":23,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Izmir","Balçova","35330","Turkey (Türkiye)",{"type":79,"coordinates":80},"Point",[81,82],27.13838,38.41273,{"lat":82,"lon":81},[85,87,89],{"name":60,"role":65,"phone":86,"phoneExt":23,"email":67},"+902324888579",{"name":69,"role":88,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"name":90,"role":88,"phone":23,"phoneExt":23,"email":23},"Caner Bektaş, MD",{"type":62,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Ridvan Aktan","Assoc. Prof., PhD","100640927",false,"NCT07584096","Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Reflux Disease","Effect of Inspiratory Muscle Training on Clinical Symptom Severity and Quality of Life in Patients With Non-erosive Reflux Disease: A Randomized Controlled Trial","Inclusion Criteria:\n\n* A clinical diagnosis of NERD,\n* No erosive lesions on endoscopy,\n* Presence of reflux symptoms for at least 3 months.\n\nExclusion Criteria:\n\n* Current use of proton pump inhibitors (PPIs) or failure to complete a minimum 2-week washout period before enrollment.\n* With known gastroduodenal ulcers\n* Diagnosed with erosive esophagitis\n* With hiatal hernia\n* With a history of gastrointestinal malignancy\n* With infectious or inflammatory gastrointestinal diseases\n* With malabsorption syndrome or gastrointestinal obstruction\n* With a history of major gastrointestinal surgery (including anti-reflux, gastric, or duodenal surgery)\n* With systemic sclerosis or other systemic connective tissue diseases\n* With severe cardiovascular, pulmonary, renal, or hepatic disease\n* With chronic respiratory diseases such as asthma or COPD\n* Having had an acute respiratory tract infection within the past 4 weeks\n* With neuromuscular diseases\n* With active tuberculosis\n* Pregnancy","ALL","18 Years","65 Years",{"count":104,"type":105},60,"ESTIMATED","INTERVENTIONAL",[108],"NA","The goal of this clinical trial is to learn if inspiratory muscle training (IMT) works to treat on clinical symptom severity and quality of life in patients with Non-erosive reflux disease (NERD). The main questions it aims to answer are:\n\nDoes drug IMT lower the clinical symptom severity ? Does drug IMT improve quality of life? Researchers will compare high intensity IMT to a sham-IMT (a IMT device with no resistance) to see if IMT lower the clinical symptom severity and improve improve quality of life.\n\nParticipants will perform the following protocol:\n\nThe IMT protocol will consist of home-based high-intensity training using a Threshold IMT device: two sets of 30 breaths with a 1-minute rest, twice daily for 4 weeks. The study group will train at 60% of baseline maximum inspiratory pressure (MIP), with weekly adjustments based on modified Borg scores (4-6), while the control group will perform sham IMT without resistance.",[111],"Non-erosive Reflux Disease (NERD)","NOT_YET_RECRUITING","2026-06-23",{"date":115,"type":116},"2026-06-24","ACTUAL",{"date":118,"type":105},"2026-07-22",{"date":120,"type":105},"2027-05-15",{"name":5,"class":6},1]