Diaphragmatic Training on GERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChanghua Christian Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 20 and 80 years.2. A confirmed diagnosis of gastroesophageal reflux disease (GERD), defined by at least one of the following criteria
Endoscopic examination within the past 3 months demonstrating Los Angeles (LA) grade A reflux esophagitis with regular use of acid-suppressive medication (e.g., proton pump inhibitors) for more than 2 months.
24-hour esophageal pH monitoring showing acid exposure time (AET) > 6%.
Endoscopic examination within the past 3 months demonstrating LA grade B or higher reflux esophagitis.
Disqualifiers
Pregnant or breastfeeding women.
History of anti-reflux surgery or other upper gastrointestinal surgical procedures related to GERD.
Presence of significant cardiopulmonary disease or chronic respiratory disease that may compromise the safety or feasibility of performing breathing training.
Inability to comply with the study protocol, including participation in training procedures and scheduled follow-up visits, due to conditions such as cognitive impairment, physical limitations, or inability to attend regular visits.
Trial design
Design model
Parallel
Treatments tested in this trial
Volume-oriented incentive spirometry
DeviceVolume-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
BehavioralDiaphragmatic 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
Usual Care Group
Other interventionParticipants 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.
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Volume-Oriented Incentive Spirometry (VIS)Experimental treatment 1 intervention
Group B: Diaphragmatic breathing exercises (DBE)Experimental treatment 1 intervention
Group C: Usual Care (Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 periodSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
Change in Distal Latency (DL)
Distal latency will be assessed using high-resolution manometry (HRM); unit :seconds
Time frame
Baseline to 6 weeks after interventionSponsors and contacts
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Source ClinicalTrials.gov