The goal of this clinical trial is to evaluate whether two types of breathing training can improve symptoms of gastroesophageal reflux disease (GERD) in adults.
The main research questions are:
* Do volume-oriented incentive spirometry (VIS) or diaphragmatic breathing exercise (DBE) improve GERD symptoms compared with usual care? * Do these breathing exercises reduce the symptoms of GERD? * Does volume-oriented incentive spirometry (VIS) produce greater improvement in GERD symptoms compared with DBE? * Do these exercises increase the strength of the lower esophageal sphincter (LES)?
Researchers will compare VIS training, DBE training, and usual care to determine whether breathing training can serve as a safe and effective non-pharmacological treatment option for GERD.
Participants will:
* Be randomly assigned to VIS training, DBE training, or usual care * Perform their assigned breathing training (if in the intervention group) twice daily for 6 weeks * Attend study visits at baseline and at week 7 for questionnaires and esophageal function tests * Keep a diary of their symptoms and breathing practice
Adults aged 20 to 80 years
Endoscopic finding of reflux esophagitis (LA grade A) with proton pump inhibitor (PPI) use > 2 months, or 24-hour pH monitoring showing acid exposure time (AET) > 6%, or endoscopic diagnosis of reflux esophagitis LA grade B or higher
Willingness to comply with the full training and follow-up protocol
Pregnant or breastfeeding women
History of anti-reflux surgery
Severe cardiopulmonary dysfunction or respiratory disease
Inability to perform the training exercises or attend follow-up visits
Parallel
Volume-Oriented Incentive Spirometer
DeviceParticipants in the experimental group will perform volume-oriented incentive spirometry training twice daily (morning and evening) for 6 weeks. Each session consists of 10 deep inspirations using the spirometer, with the target volume initially set according to the participant's predicted maximum inspiratory capacity and increased by approximately 5% each week starting from week 2. For each breath, participants inhale to reach the target volume, hold their breath for 3-5 seconds, and then exhale. A rest period of 30-60 seconds is allowed between maneuvers, and the pace is adjusted according to individual tolerance. Training is performed in a seated or semi-recumbent position.
Diaphragmatic Breathing Exercise (DBE)
BehavioralParticipants in the control group will perform diaphragmatic breathing exercises twice daily (morning and evening) for 6 weeks. During weeks 1-2, each session consists of 10 breaths per set; from week 3 to week 6, each session consists of 15 breaths per set. The exercise is performed without devices and includes the following sequence: slow inspiration through the nose with abdominal expansion, holding the breath for 5 seconds, followed by exhalation through the mouth with visible abdominal contraction. After each set, participants rest with natural breathing for 1-2 minutes to prevent hyperventilation or diaphragmatic fatigue. Training is conducted in a semi-recumbent position with both hands placed behind the head, focusing on abdominal movement control and breathing rhythm.
Usual Care and Education
BehavioralParticipants in the control group will receive usual clinical care for gastroesophageal reflux disease (GERD) without structured breathing training. At study entry, participants are provided with standardized patient education regarding GERD and lifestyle modification strategies, along with an educational leaflet. No specific posture or breathing exercises are required during the study period.
Change in lower esophageal sphincter (LES) pressure
LES pressure will be measured using high-resolution manometry (HRM). The mean resting pressure (mmHg) of the LES will be recorded and analyzed to evaluate changes from baseline to week 7 between groups
Change in GERD symptom severity measured by GERDQ
GERD-related symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GERDQ), a validated 6-item self-reported instrument. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms. Changes from baseline to week 7 will be compared between groups.
Change in the number of reflux episodes within 24 hours
Ambulatory 24-hour pH-impedance monitoring will be used to quantify the total number of gastroesophageal reflux episodes. Differences between baseline and week 7 will be assessed across groups
Change in esophageal acid exposure time (AET)
Esophageal acid exposure will be evaluated using 24-hour pH monitoring. AET is defined as the percentage of time with esophageal pH \< 4.0 during the 24-hour monitoring period. Changes from baseline to week 7 will be compared
Change in the number of effective esophageal peristalsis events
Esophageal motility will be assessed using high-resolution manometry (HRM). The number of effective peristaltic contractions within 24 hours will be recorded. Changes from baseline to week 7 will be analyzed between groups
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