Diaphragmatic Training for Gastroesophageal Reflux Disease: A Randomized Controlled Trial Comparing the Effects of Diaphragmatic Breathing Exercise and Incentive Spirometry Training on Esophageal Dynamics and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Acid exposure time (AET)
研究概览
简要总结
he goal of this clinical trial is to evaluate the effects of diaphragm-oriented breathing training on patients with gastroesophageal reflux disease (GERD). This study will compare two non-invasive respiratory interventions-diaphragmatic breathing exercise (DBE) and volume-oriented incentive spirometry (VIS)-in terms of their impact on esophageal function and health-related quality of life.The main questions it aims to answer are:Does DBE or VIS improve GERD symptoms as measured by the GERD Questionnaire (GERDQ)?Do these interventions reduce esophageal acid exposure time and the number of reflux episodes?Do these interventions improve lower esophageal sphincter (LES) pressure and esophageal motility?Do these interventions improve GERD-related quality of life as measured by the GERD-HRQL questionnaire?Researchers will compare three groups: DBE, VIS, and a control group receiving standard care, to determine whether diaphragm-oriented breathing training provides additional benefits over usual management.Participants will:Be randomly assigned to one of three groups (DBE, VIS, or control)Perform the assigned intervention for 6 weeksUndergo baseline and post-intervention assessments, including symptom questionnaires and esophageal function testing Record symptoms and adherence in a daily diary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Include Criteria:
- •Age between 20 and 80 years.
- •A confirmed diagnosis of gastroesophageal reflux disease (GERD), defined by at least one of the following criteria
- •Endoscopic examination within the past 3 months demonstrating Los Angeles (LA) grade A reflux esophagitis with regular use of acid-suppressive medication (e.g., proton pump inhibitors) for more than 2 months.
- •24-hour esophageal pH monitoring showing acid exposure time (AET) > 6%.
- •Endoscopic examination within the past 3 months demonstrating LA grade B or higher reflux esophagitis.
- •Willingness and ability to participate in the intervention program, including adherence to training protocols, scheduled follow-up visits, and completion of all required assessments during the study period.
排除标准
- •Pregnant or breastfeeding women.
- •History of anti-reflux surgery or other upper gastrointestinal surgical procedures related to GERD.
- •Presence of significant cardiopulmonary disease or chronic respiratory disease that may compromise the safety or feasibility of performing breathing training.
- •Inability to comply with the study protocol, including participation in training procedures and scheduled follow-up visits, due to conditions such as cognitive impairment, physical limitations, or inability to attend regular visits.
研究组 & 干预措施
Volume-Oriented Incentive Spirometry (VIS)
Participants assigned to the VIS group will receive volume-oriented incentive spirometry training using a standardized protocol. The intervention will be initiated under supervision, followed by home-based practice. Participants will be instructed to perform slow, deep inhalation to reach target volume levels, with brief breath-holding as tolerated, followed by relaxed exhalation. Training will be performed twice daily for approximately 20 minutes per session over a 6-week
干预措施: Volume-oriented incentive spirometry (Device)
Diaphragmatic breathing exercises (DBE)
Participants assigned to the DBE group will receive diaphragmatic breathing exercise training using a standardized protocol. The intervention will be initiated under supervision, followed by home-based practice. Participants will be instructed to perform slow, deep diaphragmatic breathing with abdominal expansion during inhalation and controlled exhalation to promote diaphragmatic activation. Training will be performed twice daily for approximately 20 minutes per session over a 6-week intervention period. Participants will continue standard medical care for GERD as needed.
干预措施: Diaphragmatic breathing exercise (Behavioral)
Usual Care (Control)
Participants assigned to the control group will receive usual care without any structured breathing training intervention. Usual care includes standard medical management for gastroesophageal reflux disease (GERD) as determined by the treating physician. Participants in this group will not receive diaphragmatic breathing exercise or incentive spirometry training during the study period.
干预措施: Usual Care Group (Other)
结局指标
主要结局
Acid exposure time (AET)
时间窗: The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period
Acid exposure time (AET) will be measured using 24-hour ambulatory esophageal pH monitoring. AET is defined as the percentage of time with esophageal pH over the total recording period
次要结局
- Change in Lower Esophageal Sphincter (LES) Resting Pressure(Baseline to 6 weeks after intervention)
- Change in Integrated Relaxation Pressure (IRP)(Baseline to 6 weeks after intervention)
- Change in Distal Contractile Integral (DCI)(Baseline to 6 weeks after intervention)
- Change in Distal Latency (DL)(Baseline to 6 weeks after intervention)
- Change in Reflux Symptom Index (RSI) Score(Baseline to 6 weeks after intervention)
- Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description(Baseline to 6 weeks after intervention)
- Change in DeMeester Score(Baseline to 6 weeks after intervention)
- Mean Nocturnal Baseline Impedance( MNBI)(Baseline to 6 weeks after intervention)
- Change in Symptom Index (SI)(Baseline to 6 weeks after intervention)
- Symptom Sensitivity Index (SSI)(Baseline to 6 weeks after intervention)
- Change in Symptom Association Probability (SAP)(Baseline to 6 weeks after intervention)
研究者
Kun-Ching Chou
MD
Changhua Christian Hospital