Gastroesophageal Reflux Disease (GERD) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Contact Information
Primary
Kun-Chin Chou, MD
84798@cch.org.tw
+886-4-723-8595
Backup
Shu-Ju Tu, NP, MSN/ PHD Candidate
79610@cch.org.tw
+886-4-723-8595
Time Frame
Start Date: 2026-03-04
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 42
Treatments
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
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.
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.
Sponsors
Leads: Changhua Christian Hospital

This content was sourced from clinicaltrials.gov