An interventional study of Volume-Oriented Incentive Spirometer and Diaphragmatic Breathing Exercise (DBE) in Incentive Spirometer, Diaphragmatic Breathing and Gastroesophageal Reflux Disease (GERD), sponsored by Changhua Christian Hospital. Not yet recruiting. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Treatment
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:
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:
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 51 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Changhua Christian Hospital is the lead sponsor of 76 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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
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)
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
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.
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.
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.
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
Time frame: Baseline and Week 7
Change in GERD symptom severity measured by GERDQ
GERD-related symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GERDQ), a validated 6-item self-reported instrument. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms. Changes from baseline to week 7 will be compared between groups.
Time frame: Baseline and Week 7
Change in the number of reflux episodes within 24 hours
Ambulatory 24-hour pH-impedance monitoring will be used to quantify the total number of gastroesophageal reflux episodes. Differences between baseline and week 7 will be assessed across groups
Time frame: Baseline and Week 7
Change in esophageal acid exposure time (AET)
Esophageal acid exposure will be evaluated using 24-hour pH monitoring. AET is defined as the percentage of time with esophageal pH \< 4.0 during the 24-hour monitoring period. Changes from baseline to week 7 will be compared
Time frame: Baseline and Week 7
Change in the number of effective esophageal peristalsis events
Esophageal motility will be assessed using high-resolution manometry (HRM). The number of effective peristaltic contractions within 24 hours will be recorded. Changes from baseline to week 7 will be analyzed between groups
Time frame: Baseline and Week 7
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) will be shared, including demographic characteristics, baseline clinical data, intervention adherence, and primary and secondary outcome measures (GERDQ scores, LES pressure, 24-hour pH-impedance results, and HRM parameters). No identifiable personal information will be included.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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