Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
NCT07544433

Diaphragmatic Training on GERD

Led by Changhua Christian Hospital · Updated on 2026-04-22

42

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Diaphragmatic Training on GERD

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 and 80 years
  • Confirmed diagnosis of gastroesophageal reflux disease (GERD) by at least one of the following:
    • Endoscopic exam within past 3 months showing Los Angeles grade A reflux esophagitis with regular acid-suppressive medication use for over 2 months
    • 24-hour esophageal pH monitoring with acid exposure time over 6%
    • Endoscopic exam within past 3 months showing Los Angeles grade B or higher reflux esophagitis
  • Willingness and ability to participate in the intervention, including adherence to training, follow-up visits, and assessments
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of anti-reflux or upper gastrointestinal surgery related to GERD
  • Significant cardiopulmonary or chronic respiratory disease that may affect safety or ability to perform breathing training
  • Inability to comply with study protocol due to cognitive impairment, physical limitations, or inability to attend visits

AI-Screening

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Trial Site Locations

Total: 1 location

1

Changhua Christian Hospital

Changhua, Changhua County, Taiwan, 50006

Actively Recruiting

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Research Team

K

Kun-Chin Chou, MD

CONTACT

S

Shu-Ju Tu, NP, MSN/ PHD Candidate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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