Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease
- Conditions
- Incentive SpirometerDiaphragmatic BreathingGastroesophageal Reflux Disease (GERD)Breath Exercise
- Registration Number
- NCT07179250
- Lead Sponsor
- Changhua Christian Hospital
- Brief Summary
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
- Detailed Description
Gastroesophageal reflux disease (GERD) is a prevalent gastrointestinal disorder resulting from dysfunction of the lower esophageal sphincter (LES) and impaired anti-reflux barrier mechanisms. While proton pump inhibitors (PPIs) are effective in reducing gastric acid secretion, up to 30-40% of patients report persistent symptoms despite optimized medical therapy. Non-pharmacological interventions are therefore of growing clinical interest.
Diaphragmatic breathing exercise (DBE) targets abdominal breathing patterns to enhance diaphragmatic tone and coordination. This may improve the esophagogastric junction competence and reduce transient LES relaxations. Volume-oriented incentive spirometry (VIS), a device providing visual feedback during sustained deep inspiration, has been demonstrated to facilitate diaphragmatic recruitment and strengthen inspiratory effort. VIS has shown benefits in perioperative recovery, pulmonary rehabilitation, and post-COVID-19 recovery, but has not yet been systematically studied in GERD populations.
This randomized controlled trial adopts a parallel three-arm design, comparing VIS training, DBE training, and a usual care control group. Participants in the intervention arms will be instructed to perform their assigned breathing training twice daily for six weeks. Standardized protocols will be applied: VIS training will target 80-90% of predicted inspiratory capacity with 3-5 seconds of breath-hold at peak inspiration, while DBE will emphasize abdominal expansion and controlled diaphragmatic contraction.
Objective outcome measures include high-resolution manometry (HRM) to assess LES basal pressure and 24-hour pH-impedance monitoring to quantify esophageal acid exposure time (AET) and reflux episodes. GERD symptom severity will be evaluated using validated questionnaires (GERDQ). Assessments are scheduled at baseline and week 7 following the intervention.
The primary hypothesis is that both VIS and DBE will improve GERD symptoms compared with usual care, with VIS expected to demonstrate superior enhancement of diaphragmatic activation and LES pressure. Secondary outcomes will explore physiological changes in esophageal acid exposure, symptom-reflux association, and intervention feasibility.
This trial is expected to generate evidence supporting safe, low-cost, and accessible non-pharmacological strategies for GERD management, complementing or potentially reducing the need for long-term pharmacotherapy.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 51
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in lower esophageal sphincter (LES) pressure Baseline and Week 7 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
- Secondary Outcome Measures
Name Time Method Change in GERD symptom severity measured by GERDQ Baseline and Week 7 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 Baseline and Week 7 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) Baseline and Week 7 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 Baseline and Week 7 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