Diaphragmatic Training on GERD

Official title

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

Overview

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

Interventions

• Device Volume-oriented incentive spirometry
  Volume-oriented incentive spirometry (VIS) is a device-based breathing intervention designed to promote slow, deep inhalation and lung expansion. Participants use an incentive spirometer to inhale to a target volume, with brief breath-holding followed by relaxed exhalation. The intervention emphasizes diaphragmatic activation and respiratory muscle training. Participants perform the training twice daily for approximately 20 minutes per session over a 6-week period. Initial instruction is provide
• Behavioral Diaphragmatic breathing exercise
  Diaphragmatic breathing exercise (DBE) is a behavioral intervention designed to enhance diaphragmatic activation and improve respiratory control. Participants will be instructed to perform slow, deep breathing with abdominal expansion during inhalation and controlled exhalation, minimizing thoracic movement. The training will be initiated under supervision, followed by home-based practice. Participants will perform the exercise twice daily for approximately 20 minutes per session over a 6-week i
• Other Usual Care Group
  Participants assigned to the control group will receive usual care for gastroesophageal reflux disease (GERD), including standard medical management and lifestyle advice as determined by the treating physician. Participants in this group will not receive diaphragmatic breathing exercise training or incentive spirometry training during the study period.

Primary outcome measures

• Acid exposure time (AET) [Time frame: The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period]

Secondary outcome measures (12)

• Change in Lower Esophageal Sphincter (LES) Resting Pressure [Time frame: Baseline to 6 weeks after intervention]
• Change in Integrated Relaxation Pressure (IRP) [Time frame: Baseline to 6 weeks after intervention]
• Change in Distal Contractile Integral (DCI) [Time frame: Baseline to 6 weeks after intervention]
• Change in Distal Latency (DL) [Time frame: Baseline to 6 weeks after intervention]
• Change in Distal Contractile Integral (DCI) [Time frame: Baseline to 6 weeks after intervention]
• Change in Reflux Symptom Index (RSI) Score [Time frame: Baseline to 6 weeks after intervention]
• Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description [Time frame: Baseline to 6 weeks after intervention]
• Change in DeMeester Score [Time frame: Baseline to 6 weeks after intervention]
• Mean Nocturnal Baseline Impedance( MNBI) [Time frame: Baseline to 6 weeks after intervention]
• Change in Symptom Index (SI) [Time frame: Baseline to 6 weeks after intervention]
• Symptom Sensitivity Index (SSI) [Time frame: Baseline to 6 weeks after intervention]
• Change in Symptom Association Probability (SAP) [Time frame: Baseline to 6 weeks after intervention]

Eligibility criteria

Include Criteria:

• Age between 20 and 80 years.2. 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• Changhua Christian Hospital — Changhua

Identifiers

NCT: NCT07544433 · CCH-251257

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗