Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-29 @ 12:26 AM
Study NCT ID:
NCT07179250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease
Sponsor:
Changhua Christian Hospital
Organization:
Study Overview
Official Title:
Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease: A Parallel Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CCH-IRB-250618 | OTHER_GRANT | Changhua Christian Hospital | View |