[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583041":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":58,"collaborators":31,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":85,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Universidade Federal de Pernambuco","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"group IMT","EXPERIMENTAL","inspiratory muscle training (IMT)",[13],"Procedure: inspiratory muscle training",{"label":15,"type":10,"description":16,"interventionNames":17},"group IMT +TM","inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)",[18],"Procedure: inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)",{"label":20,"type":21,"description":22,"interventionNames":23},"group placebo","PLACEBO_COMPARATOR","a simulated treatment protocol",[24],"Procedure: Controle",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","inspiratory muscle training","Volunteers allocated to the Sham group will receive proton pump inhibitor medication at a standard dose of 20 mg Participants will perform home-based IMT with a moderate load set at 50% of maximal inspiratory pressure (PImáx), adjusted weekly during in-person sessions at LACAP-UFPE. Training will use the Powerbreathe® Classic Light device, provided to participants for the study duration. The protocol includes three cycles of 10 explosive respiratory incursions, with one-minute rest intervals, performed twice daily for eight weeks. Participants will record perceived exertion (Borg scale) and any occurrences in a training log.",[9],null,{"type":27,"name":16,"description":33,"armGroupLabels":34,"otherNames":31},"Volunteers allocated to the group will receive proton pump inhibitor medication at a standard dose of 20 mg.\n\nThe IMT protocol will be the same as in Group 1. Intervention: IMT Combined with Manual Techniques (MTLES \\& DRT) The IMT protocol follows Group 1. DRT (Rocha et al., 2015) involves manual traction during inspiration and deepened contact during expiration, applied in two sets of ten deep breaths. MTLES (Eguaras et al., 2019) is performed with the patient seated, applying epigastric pressure to access the lower esophageal sphincter through coordinated flexion-inspiration and extension-expiration for 5 minutes.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Controle","Volunteers allocated to the Sham group will receive proton pump inhibitor medication at a standard dose of 20 mg, as prescribed for other participants. They will undergo a simulated treatment protocol, including inspiratory muscle training (IMT) without load to mimic device use and manual techniques where the therapist places hands on the intervention area without performing actual manipulation.",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},"HELENA ROCHA, Msc","CONTACT","55 81 2126-8492","hmr.fisio@gmail.com",[46],{"facility":5,"status":31,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":31},"Recife","Pernambuco","50670-901","Brazil","BR",{"type":53,"coordinates":54},"Point",[55,56],-34.88111,-8.05389,{"lat":56,"lon":55},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","HELENA MEDEIROS ROCHA","Principal Investigator","100583041","efficacy-of-inspiratory-muscle-training-associated-with-manual-techniques-in-individuals-with-gerd-100583041",false,"NCT06871163","EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES IN INDIVIDUALS WITH GERD","EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES FOR THE LOWER ESOPHAGEAL SPHINCTER AND DIAPHRAGMATIC RELEASE IN INDIVIDUALS WITH GASTROESOPHAGEAL REFLUX DISEASE: A RANDOMIZED CLINICAL TRIAL","GERD","Inclusion Criteria:\n\n* Individuals diagnosed with gastroesophageal reflux disease (GERD)\n* using 20 mg of proton pump inhibitors (PPIs).\n\nExclusion Criteria:\n\n* Individuals with a hiatal hernia \\>3 cm,\n* chronic lung diseases (chronic obstructive pulmonary disease and interstitial lung diseases)\n* severe heart diseases,\n* history of previous abdominal and\u002For thoracic surgeries, rib fractures within the past year,\n* severe osteoporosis\n* BMI \\>30 kg\u002Fm²","ALL","18 Years","74 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","The objective of this clinical trial is to investigate the efficacy of inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT) in patients with Gastroesophageal Reflux Disease (GERD). The main questions it aims to answer are:\n\n1. If the combination of IMT, DRT, and MTLES can improve GERD symptoms and patients' quality of life.\n2. If the home-based IMT protocol, with weekly adjustments, and the manual techniques applied twice a week can have a positive impact on various clinical measures, such as pressure at the lower esophageal sphincter, reflux episodes, and quality of life.\n\nThe researchers will compare three groups: Group 1 (IMT), Group 2 (IMT + DRT + MTLES), and Group 3 (control, sham), to see if the group receiving IMT combined with DRT and MTLES shows greater improvements compared to the control group.\n\nParticipants will perform inspiratory muscle training at home, following a protocol adjusted weekly, and will receive manual techniques twice a week.",[81],"Gastroesophageal Reflux Disease (GERD)",[11,83,84],"diaphragmatic release","manual techniques for the lower esophageal sphincter","NOT_YET_RECRUITING","2025-03-06",{"date":88,"type":89},"2025-03-11","ACTUAL",{"date":91,"type":75},"2025-04",{"date":93,"type":75},"2027-02",{"name":5,"class":6},1]