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NCT Number: NCT07544433

Diaphragmatic Training on GERD

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

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Key information

Conditions

GERD Deglutition Disorders Diaphragmatic Training Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital

Changhua, Changhua County, 50006, Taiwan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Include Criteria:

  • Age between 20 and 80 years.2. A confirmed diagnosis of gastroesophageal reflux disease (GERD), defined by at least one of the following criteria
  • Endoscopic examination within the past 3 months demonstrating Los Angeles (LA) grade A reflux esophagitis with regular use of acid-suppressive medication (e.g., proton pump inhibitors) for more than 2 months.
  • 24-hour esophageal pH monitoring showing acid exposure time (AET) > 6%.
  • Endoscopic examination within the past 3 months demonstrating LA grade B or higher reflux esophagitis.
  • Willingness and ability to participate in the intervention program, including adherence to training protocols, scheduled follow-up visits, and completion of all required assessments during the study period.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Acid exposure time (AET)

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

    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

Secondary outcomes

  1. Change in Lower Esophageal Sphincter (LES) Resting Pressure

    Time frame: Baseline to 6 weeks after intervention

    Lower esophageal sphincter resting pressure will be measured using high-resolution manometry (HRM); unit: mmHg

  2. Change in Integrated Relaxation Pressure (IRP)

    Time frame: Baseline to 6 weeks after intervention

    Integrated relaxation pressure will be assessed using high-resolution manometry (HRM); unit: mmHg.

  3. Change in Distal Contractile Integral (DCI)

    Time frame: Baseline to 6 weeks after intervention

    Distal contractile integral will be measured using high-resolution manometry (HRM); unit: mmHg·cm·s

  4. Change in Distal Latency (DL)

    Time frame: Baseline to 6 weeks after intervention

    Distal latency will be assessed using high-resolution manometry (HRM); unit :seconds

  5. Change in Distal Contractile Integral (DCI)

    Time frame: Baseline to 6 weeks after intervention

    Distal contractile integral will be measured using high-resolution manometry (HRM) to assess the vigor of distal esophageal peristaltic contractions; unit: mmHg·cm·s

  6. Change in Reflux Symptom Index (RSI) Score

    Time frame: Baseline to 6 weeks after intervention

    Laryngopharyngeal reflux-related symptoms will be assessed using the Reflux Symptom Index (RSI), a validated 9-item questionnaire evaluating symptoms such as hoarseness, throat clearing, cough, and globus sensation. Each item is scored from 0 to 5, with total scores ranging from 0 to 45.

  7. Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description

    Time frame: Baseline to 6 weeks after intervention

    GERD symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GERDQ), a validated six-item questionnaire evaluating reflux-related symptoms during the past week. Total scores range from 0 to 18.

  8. Change in DeMeester Score

    Time frame: Baseline to 6 weeks after intervention

    DeMeester score will be calculated from 24-hour esophageal pH monitoring data to quantify esophageal acid exposure. The composite score includes six parameters derived from pH monitoring.

  9. Mean Nocturnal Baseline Impedance( MNBI)

    Time frame: Baseline to 6 weeks after intervention

    Mean nocturnal baseline impedance will be derived from 24-hour multichannel intraluminal impedance-pH monitoring and reflects esophageal mucosal integrity during nocturnal periods; unit: Ohms (Ω)

  10. Change in Symptom Index (SI)

    Time frame: Baseline to 6 weeks after intervention

    Symptom Index will be calculated using 24-hour multichannel intraluminal impedance-pH monitoring to assess the proportion of symptom events associated with reflux episodes; unit:%

  11. Symptom Sensitivity Index (SSI)

    Time frame: Baseline to 6 weeks after intervention

    Symptom Sensitivity Index will be calculated using 24-hour multichannel intraluminal impedance-pH monitoring to determine the proportion of reflux episodes associated with symptom events; unit:%

  12. Change in Symptom Association Probability (SAP)

    Time frame: Baseline to 6 weeks after intervention

    Symptom Association Probability will be calculated using 24-hour multichannel intraluminal impedance-pH monitoring to evaluate the statistical association between reflux episodes and symptom events; unit:%

Study contacts

Contact information is provided by the study sponsor or research team.

Kun-Chin Chou, MD

CONTACT

[email protected]

+886-4-723-8595 ext. 5501

Shu-Ju Tu, NP, MSN/ PHD Candidate

CONTACT

[email protected]

+886-4-723-8595 ext. 7591

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Acronym: GERD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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