Short-term and long-term effect of diaphragmatic breathing training on reflux symptoms, quality of life, proton pump inhibitor consumption and severity of reflux exposure in patients with gastroesophageal reflux disease unresponsive to conservative management: a prospective, self-controlled bicentric study

Charles University0 个研究点目标入组 40 人开始时间: 2023年6月5日最近更新: 2024年8月19日

适应症

试验速览

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•1. Patients with GERD with persistent symptoms despite lifestyle modification and maintenance therapy with proton pump inhibitors, or patients who cannot discontinue antireflux medication due to early recurrence of their symptoms.
•GERD is diagnosed by positive EGDS and/or positive 24-hour esophageal pH monitoring with impedance and symptoms of GERD are present for at least 6 months prior to diagnosis.
•1.1. Positive EGDS = evidence of reflux esophagitis according to the Los Angeles classification
•1.2. Positive 24-hour esophageal pH monitoring with impedance = AET > 6% and/or number of reflux episodes >80/24 h performed without antireflux medication (off proton pump inhibitor [PPI] 14 days prior to testing)
•2. Patients with GERD who are interested in incorporating diaphragmatic breathing training into their treatment
•3. PPI dosing on a long-term on-demand basis or regular basis, in either a standard dose (once daily) or full dose (twice daily).
•4. Age 18 years and above
•5. Signed informed consent

•1. Severe reflux esophagitis, i.e. reflux esophagitis LA C and D, esophageal stenosis undergoing dilatation therapy, esophageal varices
•2. Other primary esophageal diseases such as achalasia, esophageal tumors
•3. Behavioural oesophageal disorders such as rumination and supragastric belching
•4. Large hiatal hernia, i.e. manometric EGJ type III with LES-CD separation =3 cm
•5. Severe comorbidities (diabetes mellitus with organ complications, advanced organ failure, i.e. chronic heart failure, severe COPD, severe renal or hepatic dysfunction, scleroderma or other connective tissue disease, mental disorders, neuropathy)
•6. Other GIT disorders requiring regular antisecretory medication that do not allow discontinuation (e.g., Barrett's esophagus, gastroduodenal ulcer disease)
•7. Pregnancy, lactation
•8. Morbid obesity with BMI above 35 kg/m²
•9. Severe musculoskeletal conditions or disorders not allowing training and practice of diaphragmatic breathing (e.g. conditions following spinal surgery)
•10. Inability to undergo EGDS, HRM and 24-hour esophageal pH monitoring with impedance (e.g. conditions following nasal surgery with inability to insert transnasal probes)

发起方

Charles University