Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID07544433

Diaphragmatic Training for Gastroesophageal Reflux Disease: A Randomized Controlled Trial Comparing Diaphragmatic Breathing Exercise and Incentive Spirometry Training on Esophageal Function and Quality of Life

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

42

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of diaphragm-focused breathing training on adults with gastroesophageal reflux disease (GERD). The study compares two non-invasive breathing methods: diaphragmatic breathing exercise (DBE) and volume-oriented incentive spirometry (VIS). It aims to see how these interventions impact GERD symptoms, esophageal acid exposure, lower esophageal sphincter pressure, esophageal movement, and quality of life compared to usual care. The trial is randomized and includes a control group receiving standard medical management. Participants are randomly assigned to one of three groups: DBE, VIS, or control. The DBE group practices slow, deep breathing with abdominal expansion twice daily for about 20 minutes over six weeks. The VIS group uses a spirometry device to perform slow, deep inhalations with breath-holding twice daily for the same duration. Both interventions begin with supervised training followed by home practice. The control group continues usual GERD care without breathing training. During the study, participants complete baseline and post-intervention assessments, including symptom questionnaires and tests of esophageal function. They keep daily diaries to record symptoms and adherence to training. Researchers will measure changes in acid exposure time, lower esophageal sphincter pressure, esophageal motility parameters, and quality of life scores from the start to the end of the six-week intervention period. Weekly phone calls support adherence and address any difficulties throughout the study.

CONDITIONS

Brief 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 one or more of the following: endoscopy showing Los Angeles grade A esophagitis with regular acid-suppressive medication use for over 2 months, 24-hour esophageal pH monitoring with acid exposure time over 6%, or endoscopy showing Los Angeles grade B or higher esophagitis within the past 3 months
  • Willingness and ability to participate in the breathing training and follow all study procedures including scheduled visits and assessments
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of anti-reflux surgery or other upper gastrointestinal surgery related to GERD
  • Presence of significant heart or lung disease or chronic respiratory conditions that make breathing training unsafe or impractical
  • Inability to comply with the study protocol due to cognitive, physical, or attendance limitations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 6 weeks

Participants receive training with either volume-oriented incentive spirometry or diaphragmatic breathing exercises, or continue with usual care for GERD. Training is initially supervised, then performed at home twice daily for approximately 20 minutes per session over a 6-week period. Weekly telephone follow-up is conducted to support compliance and address any issues.

1 initial supervised visit and weekly telephone follow-up for 6 weeks

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

S

Shu-Ju Tu, NP, MSN/ PHD Candidate

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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