Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

Summary

The goal of this clinical trial is to evaluate whether two types of breathing training can improve symptoms of gastroesophageal reflux disease (GERD) in adults.

The main research questions are:

* Do volume-oriented incentive spirometry (VIS) or diaphragmatic breathing exercise (DBE) improve GERD symptoms compared with usual care?
* Do these breathing exercises reduce the symptoms of GERD?
* Does volume-oriented incentive spirometry (VIS) produce greater improvement in GERD symptoms compared with DBE?
* Do these exercises increase the strength of the lower esophageal sphincter (LES)?

Researchers will compare VIS training, DBE training, and usual care to determine whether breathing training can serve as a safe and effective non-pharmacological treatment option for GERD.

Participants will:

* Be randomly assigned to VIS training, DBE training, or usual care
* Perform their assigned breathing training (if in the intervention group) twice daily for 6 weeks
* Attend study visits at baseline and at week 7 for questionnaires and esophageal function tests
* Keep a diary of their symptoms and breathing practice

Conditions

• Incentive Spirometer
• Diaphragmatic Breathing
• Gastroesophageal Reflux Disease (GERD)
• Breath Exercise

Interventions

DEVICE

Volume-Oriented Incentive Spirometer

Participants in the experimental group will perform volume-oriented incentive spirometry training twice daily (morning and evening) for 6 weeks. Each session consists of 10 deep inspirations using the spirometer, with the target volume initially set according to the participant's predicted maximum inspiratory capacity and increased by approximately 5% each week starting from week 2. For each breath, participants inhale to reach the target volume, hold their breath for 3-5 seconds, and then exhale. A rest period of 30-60 seconds is allowed between maneuvers, and the pace is adjusted according to individual tolerance. Training is performed in a seated or semi-recumbent position.

BEHAVIORAL

Diaphragmatic Breathing Exercise (DBE)

Participants in the control group will perform diaphragmatic breathing exercises twice daily (morning and evening) for 6 weeks. During weeks 1-2, each session consists of 10 breaths per set; from week 3 to week 6, each session consists of 15 breaths per set. The exercise is performed without devices and includes the following sequence: slow inspiration through the nose with abdominal expansion, holding the breath for 5 seconds, followed by exhalation through the mouth with visible abdominal contraction. After each set, participants rest with natural breathing for 1-2 minutes to prevent hyperventilation or diaphragmatic fatigue. Training is conducted in a semi-recumbent position with both hands placed behind the head, focusing on abdominal movement control and breathing rhythm.

BEHAVIORAL

Usual Care and Education

Participants in the control group will receive usual clinical care for gastroesophageal reflux disease (GERD) without structured breathing training. At study entry, participants are provided with standardized patient education regarding GERD and lifestyle modification strategies, along with an educational leaflet. No specific posture or breathing exercises are required during the study period.

Sponsors & Collaborators

• Changhua Christian Hospital

  lead OTHER

Principal Investigators

• Shu-Ju Tu, MSN, NP, RN · Changhua Christian Hospital, Dept. of Gastroenterology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2026-02-28

Completion

2026-05-31