Diaphragmatic Training on GERD

NCT07544433 | Recruiting

• 1 other identifier: CCH-251257
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

GERD; incentive spirometry; esophageal dynamics; quality of life; Diaphragmatic training; diaphragmatic breathing exercise; incentive spirometry training

Outcome Measures

Primary Outcomes (1)

• Acid exposure time (AET)

  Acid exposure time (AET) will be measured using 24-hour ambulatory esophageal pH monitoring. AET is defined as the percentage of time with esophageal pH over the total recording period

  The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period

Secondary Outcomes (12)

• Change in Lower Esophageal Sphincter (LES) Resting Pressure

  Baseline to 6 weeks after intervention

• Change in Integrated Relaxation Pressure (IRP)

  Baseline to 6 weeks after intervention

• Change in Distal Contractile Integral (DCI)

  Baseline to 6 weeks after intervention

• Change in Distal Latency (DL)

  Baseline to 6 weeks after intervention

• Change in Distal Contractile Integral (DCI)

  Baseline to 6 weeks after intervention

Study Arms (3)

Volume-Oriented Incentive Spirometry (VIS)

EXPERIMENTAL

Participants assigned to the VIS group will receive volume-oriented incentive spirometry training using a standardized protocol. The intervention will be initiated under supervision, followed by home-based practice. Participants will be instructed to perform slow, deep inhalation to reach target volume levels, with brief breath-holding as tolerated, followed by relaxed exhalation. Training will be performed twice daily for approximately 20 minutes per session over a 6-week

Device: Volume-oriented incentive spirometry

Diaphragmatic breathing exercises (DBE)

EXPERIMENTAL

Participants assigned to the DBE group will receive diaphragmatic breathing exercise training using a standardized protocol. The intervention will be initiated under supervision, followed by home-based practice. Participants will be instructed to perform slow, deep diaphragmatic breathing with abdominal expansion during inhalation and controlled exhalation to promote diaphragmatic activation. Training will be performed twice daily for approximately 20 minutes per session over a 6-week intervention period. Participants will continue standard medical care for GERD as needed.

Behavioral: Diaphragmatic breathing exercise

Usual Care (Control)

ACTIVE COMPARATOR

Participants assigned to the control group will receive usual care without any structured breathing training intervention. Usual care includes standard medical management for gastroesophageal reflux disease (GERD) as determined by the treating physician. Participants in this group will not receive diaphragmatic breathing exercise or incentive spirometry training during the study period.

Other: Usual Care Group

Interventions

Volume-oriented incentive spirometry DEVICE

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.

Volume-Oriented Incentive Spirometry (VIS)

Diaphragmatic breathing exercise BEHAVIORAL

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

Diaphragmatic breathing exercises (DBE)

Usual Care Group OTHER

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.

Usual Care (Control)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnant or breastfeeding women.
• History of anti-reflux surgery or other upper gastrointestinal surgical procedures related to GERD.
• Presence of significant cardiopulmonary disease or chronic respiratory disease that may compromise the safety or feasibility of performing breathing training.
• Inability to comply with the study protocol, including participation in training procedures and scheduled follow-up visits, due to conditions such as cognitive impairment, physical limitations, or inability to attend regular visits.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Changhua County, 50006, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Kun-Chin Chou, MD

CONTACT

+886-4-723-8595; 84798@cch.org.tw

Shu-Ju Tu, NP, MSN/ PHD Candidate

CONTACT

+886-4-723-8595; 79610@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This study is a prospective, three-arm, randomized, parallel-group controlled trial evaluating diaphragm-oriented functional training in patients with gastroesophageal reflux disease (GERD). Participants will be randomly assigned in a 1:1:1 ratio to diaphragmatic breathing exercise (DBE), volume-oriented incentive spirometry (VIS), or standard care.Randomization will use a computer-generated sequence with allocation concealment. Blinding of participants is not feasible due to the behavioral nature of the interventions; however, outcome assessors and data analysts will be blinded.Interventions will be delivered independently with no crossover. Measures will minimize contamination, and participants will not be informed of other group protocols. Assessments will be conducted at baseline and post-intervention.Outcomes include acid exposure time, reflux episodes, symptom severity, and esophageal motility parameters.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 22, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-03

Locations

TW (1)