An interventional study of Volume-oriented incentive spirometry and Diaphragmatic breathing exercise in GERD and Diaphragmatic Training, sponsored by Changhua Christian Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Supportive care
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
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 42 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.
Counted across the registry records on this site, refreshed daily.
Include Criteria:
Exclusion Criteria
Participants assigned to the VIS group will receive volume-oriented incentive spirometry training using a standardized protocol. The intervention will be initiated under supervision, followed by home-based practice. Participants will be instructed to perform slow, deep inhalation to reach target volume levels, with brief breath-holding as tolerated, followed by relaxed exhalation. Training will be performed twice daily for approximately 20 minutes per session over a 6-week
Device: Volume-oriented incentive spirometry
Participants assigned to the DBE group will receive diaphragmatic breathing exercise training using a standardized protocol. The intervention will be initiated under supervision, followed by home-based practice. Participants will be instructed to perform slow, deep diaphragmatic breathing with abdominal expansion during inhalation and controlled exhalation to promote diaphragmatic activation. Training will be performed twice daily for approximately 20 minutes per session over a 6-week intervention period. Participants will continue standard medical care for GERD as needed.
Behavioral: Diaphragmatic breathing exercise
Participants assigned to the control group will receive usual care without any structured breathing training intervention. Usual care includes standard medical management for gastroesophageal reflux disease (GERD) as determined by the treating physician. Participants in this group will not receive diaphragmatic breathing exercise or incentive spirometry training during the study period.
Other: Usual Care Group
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 (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
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.
Acid exposure time (AET)
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
Time frame: The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period
Change in Lower Esophageal Sphincter (LES) Resting Pressure
Lower esophageal sphincter resting pressure will be measured using high-resolution manometry (HRM); unit: mmHg
Time frame: Baseline to 6 weeks after intervention
Change in Integrated Relaxation Pressure (IRP)
Integrated relaxation pressure will be assessed using high-resolution manometry (HRM); unit: mmHg.
Time frame: Baseline to 6 weeks after intervention
Change in Distal Contractile Integral (DCI)
Distal contractile integral will be measured using high-resolution manometry (HRM); unit: mmHg·cm·s
Time frame: Baseline to 6 weeks after intervention
Change in Distal Latency (DL)
Distal latency will be assessed using high-resolution manometry (HRM); unit :seconds
Time frame: Baseline to 6 weeks after intervention
Change in Distal Contractile Integral (DCI)
Distal contractile integral will be measured using high-resolution manometry (HRM) to assess the vigor of distal esophageal peristaltic contractions; unit: mmHg·cm·s
Time frame: Baseline to 6 weeks after intervention
Change in Reflux Symptom Index (RSI) Score
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.
Time frame: Baseline to 6 weeks after intervention
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description
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.
Time frame: Baseline to 6 weeks after intervention
Change in DeMeester Score
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.
Time frame: Baseline to 6 weeks after intervention
Mean Nocturnal Baseline Impedance( MNBI)
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)
Time frame: Baseline to 6 weeks after intervention
Change in Symptom Index (SI)
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:%
Time frame: Baseline to 6 weeks after intervention
Symptom Sensitivity Index (SSI)
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:%
Time frame: Baseline to 6 weeks after intervention
Change in Symptom Association Probability (SAP)
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:%
Time frame: Baseline to 6 weeks after intervention
Plan to share: Undecided
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Started Mar 2026 (actual). Primary completion is estimated for Sep 2028, 30 months after the start.
Of 192 non-industry interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 68. This study's planned 30 months is close to that.
Counting every sponsor, half of 225 studies reached it within 32 months; a quarter within 12 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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