Diaphragmatic Training on GERD (GERD)

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

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

Study Overview

• Status: Recruiting
• Conditions: GERD; Diaphragmatic Training
• Intervention / Treatment: Device: Volume-oriented incentive spirometry; Behavioral: Diaphragmatic breathing exercise; Other: Usual Care Group

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun-Chin Chou, MD; Phone Number: 5501 +886-4-723-8595; Email: 84798@cch.org.tw
• Study Contact Backup: Name: Shu-Ju Tu, NP, MSN/ PHD Candidate; Phone Number: 7591 +886-4-723-8595; Email: 79610@cch.org.tw

Study Locations

• Taiwan
  • Changhua County
    • Changhua, Changhua County, Taiwan, 50006
      • Recruiting
      • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 provided under supervision, followed by home-based practice. Adherence is monitored using daily training logs, and participants receive weekly telephone follow-up to reinforce compliance and address any difficulties. No additional breathing exercises are permitted during the study period.
Experimental: 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.	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 intervention period. Adherence will be monitored using daily training logs, and weekly telephone follow-up will be conducted to reinforce compliance and address potential difficulties. No additional breathing exercises will be permitted during the study period. Participants will continue standard medical care for GERD as needed
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acid exposure time (AET)	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	The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lower Esophageal Sphincter (LES) Resting Pressure	Lower esophageal sphincter resting pressure will be measured using high-resolution manometry (HRM); unit: mmHg	Baseline to 6 weeks after intervention
Change in Integrated Relaxation Pressure (IRP)	Integrated relaxation pressure will be assessed using high-resolution manometry (HRM); unit: mmHg.	Baseline to 6 weeks after intervention
Change in Distal Contractile Integral (DCI)	Distal contractile integral will be measured using high-resolution manometry (HRM); unit: mmHg·cm·s	Baseline to 6 weeks after intervention
Change in Distal Latency (DL)	Distal latency will be assessed using high-resolution manometry (HRM); unit :seconds	Baseline to 6 weeks after intervention
Change in Distal Contractile Integral (DCI)	Distal contractile integral will be measured using high-resolution manometry (HRM) to assess the vigor of distal esophageal peristaltic contractions; unit: mmHg·cm·s	Baseline to 6 weeks after intervention
Change in Reflux Symptom Index (RSI) Score	Laryngopharyngeal reflux-related symptoms will be assessed using the Reflux Symptom Index (RSI), a validated 9-item questionnaire evaluating symptoms such as hoarseness, throat clearing, cough, and globus sensation. Each item is scored from 0 to 5, with total scores ranging from 0 to 45.	Baseline to 6 weeks after intervention
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description	GERD symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GERDQ), a validated six-item questionnaire evaluating reflux-related symptoms during the past week. Total scores range from 0 to 18.	Baseline to 6 weeks after intervention
Change in DeMeester Score	DeMeester score will be calculated from 24-hour esophageal pH monitoring data to quantify esophageal acid exposure. The composite score includes six parameters derived from pH monitoring.	Baseline to 6 weeks after intervention
Mean Nocturnal Baseline Impedance( MNBI)	Mean nocturnal baseline impedance will be derived from 24-hour multichannel intraluminal impedance-pH monitoring and reflects esophageal mucosal integrity during nocturnal periods; unit: Ohms (Ω)	Baseline to 6 weeks after intervention
Change in Symptom Index (SI)	Symptom Index will be calculated using 24-hour multichannel intraluminal impedance-pH monitoring to assess the proportion of symptom events associated with reflux episodes; unit:%	Baseline to 6 weeks after intervention
Symptom Sensitivity Index (SSI)	Symptom Sensitivity Index will be calculated using 24-hour multichannel intraluminal impedance-pH monitoring to determine the proportion of reflux episodes associated with symptom events; unit:%	Baseline to 6 weeks after intervention
Change in Symptom Association Probability (SAP)	Symptom Association Probability will be calculated using 24-hour multichannel intraluminal impedance-pH monitoring to evaluate the statistical association between reflux episodes and symptom events; unit:%	Baseline to 6 weeks after intervention

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: GERD; quality of life; diaphragmatic breathing exercise; incentive spirometry; esophageal dynamics; Diaphragmatic training; incentive spirometry training
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: CCH-251257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No