About this trial
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).
The main questions it aims to answer are:
Does 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.
Participants will:
Complete baseline clinical evaluations and symptom questionnaires. Be randomly assigned to either the VIS-assisted DBE group or the usual care group.
Receive 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.
Complete follow-up assessments after the 4-week intervention, including symptom and quality-of-life questionnaires
Eligibility criteria
Qualifiers
Adults aged 20 to 100 years.
Diagnosis of functional heartburn (FH) or reflux hypersensitivity (RH) according to the Rome IV criteria.
Normal upper gastrointestinal endoscopy without evidence of erosive esophagitis, Barrett's esophagus, or hiatal hernia.
Normal esophageal motility on high-resolution manometry (HRM) according to the Chicago Classification Version 4.0.
Disqualifiers
Pregnant or breastfeeding women.
Severe cardiopulmonary dysfunction or chronic respiratory disease.
Inability to perform diaphragmatic breathing exercises or comply with the study protocol and scheduled follow-up visits
Trial design
Treatments tested in this trial
- Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise
- standard pharmacological treatment with lifestyle modification education