Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

NCT ID: NCT07179250

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-05-31

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

Detailed Description

Gastroesophageal reflux disease (GERD) is a prevalent gastrointestinal disorder resulting from dysfunction of the lower esophageal sphincter (LES) and impaired anti-reflux barrier mechanisms. While proton pump inhibitors (PPIs) are effective in reducing gastric acid secretion, up to 30-40% of patients report persistent symptoms despite optimized medical therapy. Non-pharmacological interventions are therefore of growing clinical interest.

Diaphragmatic breathing exercise (DBE) targets abdominal breathing patterns to enhance diaphragmatic tone and coordination. This may improve the esophagogastric junction competence and reduce transient LES relaxations. Volume-oriented incentive spirometry (VIS), a device providing visual feedback during sustained deep inspiration, has been demonstrated to facilitate diaphragmatic recruitment and strengthen inspiratory effort. VIS has shown benefits in perioperative recovery, pulmonary rehabilitation, and post-COVID-19 recovery, but has not yet been systematically studied in GERD populations.

This randomized controlled trial adopts a parallel three-arm design, comparing VIS training, DBE training, and a usual care control group. Participants in the intervention arms will be instructed to perform their assigned breathing training twice daily for six weeks. Standardized protocols will be applied: VIS training will target 80-90% of predicted inspiratory capacity with 3-5 seconds of breath-hold at peak inspiration, while DBE will emphasize abdominal expansion and controlled diaphragmatic contraction.

Objective outcome measures include high-resolution manometry (HRM) to assess LES basal pressure and 24-hour pH-impedance monitoring to quantify esophageal acid exposure time (AET) and reflux episodes. GERD symptom severity will be evaluated using validated questionnaires (GERDQ). Assessments are scheduled at baseline and week 7 following the intervention.

The primary hypothesis is that both VIS and DBE will improve GERD symptoms compared with usual care, with VIS expected to demonstrate superior enhancement of diaphragmatic activation and LES pressure. Secondary outcomes will explore physiological changes in esophageal acid exposure, symptom-reflux association, and intervention feasibility.

This trial is expected to generate evidence supporting safe, low-cost, and accessible non-pharmacological strategies for GERD management, complementing or potentially reducing the need for long-term pharmacotherapy.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Volume-Oriented Incentive Spirometry (VIS)

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.

Group Type: EXPERIMENTAL

Volume-Oriented Incentive Spirometer

Intervention Type: 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.

Diaphragmatic Breathing Exercises (DBE)

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.

Group Type: EXPERIMENTAL

Diaphragmatic Breathing Exercise (DBE)

Intervention Type: 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.

Usual Care (Control)

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.

Group Type: PLACEBO_COMPARATOR

Usual Care and Education

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu-Ju Tu, MSN, NP, RN

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital, Dept. of Gastroenterology

Central Contacts

Shu-Ju Tu, MSN, NP, RN

Role: CONTACT

79610@gmail.com

+886-4-723-8595 ext. 7591

Kun Ching Chou, MD

Role: CONTACT

84798@cch.org.tw

+886-4-723-8595 ext. 5501

Other Identifiers

CCH-IRB-250618

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CCH-IRB-250618

Identifier Type: -

Identifier Source: org_study_id