Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

NCT07179250 | Not Yet Recruiting

• 1 other identifier: CCH-IRB-250618
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

GERD; Gastroesophageal Reflux Disease; Acid Reflux; Diaphragmatic Breathing; Breathing Training; Incentive Spirometer; Volume-Oriented Incentive Spirometry; GERDQ; Gastroesophageal Reflux Disease Questionnaire; breath exercise

Outcome Measures

Primary Outcomes (1)

• Change in lower esophageal sphincter (LES) pressure

  LES pressure will be measured using high-resolution manometry (HRM). The mean resting pressure (mmHg) of the LES will be recorded and analyzed to evaluate changes from baseline to week 7 between groups

  Baseline and Week 7

Secondary Outcomes (4)

• Change in GERD symptom severity measured by GERDQ

  Baseline and Week 7

• Change in the number of reflux episodes within 24 hours

  Baseline and Week 7

• Change in esophageal acid exposure time (AET)

  Baseline and Week 7

• Change in the number of effective esophageal peristalsis events

  Baseline and Week 7

Study Arms (3)

Volume-Oriented Incentive Spirometry (VIS)

EXPERIMENTAL

Participants in this group will perform diaphragmatic breathing exercises twice daily for 6 weeks using a volume-oriented incentive spirometer, in addition to usual care. Assessments will be conducted at baseline and at the end of week 7.

Device: Volume-Oriented Incentive Spirometer

Diaphragmatic Breathing Exercises (DBE)

EXPERIMENTAL

In this group will perform standard diaphragmatic breathing exercises twice daily for 6 weeks, in addition to usual care. Assessments will be conducted at baseline and at the end of week 7.

Behavioral: Diaphragmatic Breathing Exercise (DBE)

Usual Care (Control)

PLACEBO COMPARATOR

Participants in this group will receive standard clinical management for gastroesophageal reflux disease without structured breathing training. Assessments will be conducted at baseline and at the end of week 7.

Behavioral: Usual Care and Education

Interventions

Volume-Oriented Incentive Spirometer DEVICE

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.

Volume-Oriented Incentive Spirometry (VIS)

Diaphragmatic Breathing Exercise (DBE) BEHAVIORAL

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.

Diaphragmatic Breathing Exercises (DBE)

Usual Care and Education BEHAVIORAL

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.

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 qualify if:

• Adults aged 20 to 80 years
• Endoscopic finding of reflux esophagitis (LA grade A) with proton pump inhibitor (PPI) use \> 2 months, or 24-hour pH monitoring showing acid exposure time (AET) \> 6%, or endoscopic diagnosis of reflux esophagitis LA grade B or higher
• Willingness to comply with the full training and follow-up protocol

You may not qualify if:

• Pregnant or breastfeeding women
• History of anti-reflux surgery
• Severe cardiopulmonary dysfunction or respiratory disease
• Inability to perform the training exercises or attend follow-up visits

Sponsors & Collaborators

• Changhua Christian Hospital: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Shu-Ju Tu, MSN, NP, RN

  Changhua Christian Hospital, Dept. of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Ju Tu, MSN, NP, RN

CONTACT

+886-4-723-8595; 79610@gmail.com

Kun Ching Chou, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses a single-blind design. Outcome assessors analyzing GERDQ questionnaires, high-resolution manometry, and 24-hour pH-impedance data are blinded to group assignments, while participants, care providers, and investigators are aware of interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled trial adopts a parallel assignment model with three arms: volume-oriented incentive spirometry (VIS), diaphragmatic breathing exercise (DBE), and usual care (control). Participants are randomized in a 1:1:1 ratio using a computer-generated sequence with allocation concealment through sealed opaque envelopes. The intervention period lasts 6 weeks, and assessments are performed at baseline and week 7. No crossover between groups is planned.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data and supporting information (study protocol, SAP) will be available beginning 6 months after publication of the primary results. Data will remain available for 3 years after publication.
• Access Criteria: Data will be available to qualified researchers for purposes of meta-analysis or secondary research related to gastroesophageal reflux disease. Requests should be submitted to the Principal Investigator by email. Access will be granted after review and approval of a reasonable research proposal, and a data use agreement may be required.