Diaphragmatic Training on GERD

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

Conditions

• GERD
• Diaphragmatic Training

Interventions

DEVICE

Volume-oriented incentive spirometry

Volume-oriented incentive spirometry (VIS) is a device-based breathing intervention designed to promote slow, deep inhalation and lung expansion. Participants use an incentive spirometer to inhale to a target volume, with brief breath-holding followed by relaxed exhalation. The intervention emphasizes diaphragmatic activation and respiratory muscle training. Participants perform the training twice daily for approximately 20 minutes per session over a 6-week period. Initial instruction is provided under supervision, followed by home-based practice. Adherence is monitored using daily training logs, and participants receive weekly telephone follow-up to reinforce compliance and address any difficulties. No additional breathing exercises are permitted during the study period.

BEHAVIORAL

Diaphragmatic breathing exercise

Diaphragmatic breathing exercise (DBE) is a behavioral intervention designed to enhance diaphragmatic activation and improve respiratory control. Participants will be instructed to perform slow, deep breathing with abdominal expansion during inhalation and controlled exhalation, minimizing thoracic movement. The training will be initiated under supervision, followed by home-based practice. Participants will perform the exercise twice daily for approximately 20 minutes per session over a 6-week intervention period. Adherence will be monitored using daily training logs, and weekly telephone follow-up will be conducted to reinforce compliance and address potential difficulties. No additional breathing exercises will be permitted during the study period. Participants will continue standard medical care for GERD as needed

OTHER

Usual Care Group

Participants assigned to the control group will receive usual care for gastroesophageal reflux disease (GERD), including standard medical management and lifestyle advice as determined by the treating physician. Participants in this group will not receive diaphragmatic breathing exercise training or incentive spirometry training during the study period.

Sponsors & Collaborators

• Changhua Christian Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-04

Primary Completion

2028-09-30

Completion

2028-09-30

Countries

• Taiwan

Study Locations