Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease: A Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 51
- 主要终点
- Change in lower esophageal sphincter (LES) pressure
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study uses a single-blind design. Outcome assessors analyzing GERDQ questionnaires, high-resolution manometry, and 24-hour pH-impedance data are blinded to group assignments, while participants, care providers, and investigators are aware of interventions.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in lower esophageal sphincter (LES) pressure
时间窗: 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
次要结局
- Change in GERD symptom severity measured by GERDQ(Baseline and Week 7)
- Change in the number of reflux episodes within 24 hours(Baseline and Week 7)
- Change in esophageal acid exposure time (AET)(Baseline and Week 7)
- Change in the number of effective esophageal peristalsis events(Baseline and Week 7)