Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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