GERD, Diaphragmatic Training
Conditions
Keywords
GERD, incentive spirometry, esophageal dynamics, quality of life, Diaphragmatic training, diaphragmatic breathing exercise, incentive spirometry training
Brief summary
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
Interventions
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.
BEHAVIORALDiaphragmatic breathing exercise
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
OTHERUsual Care Group
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.
Sponsors
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study is a prospective, three-arm, randomized, parallel-group controlled trial evaluating diaphragm-oriented functional training in patients with gastroesophageal reflux disease (GERD). Participants will be randomly assigned in a 1:1:1 ratio to diaphragmatic breathing exercise (DBE), volume-oriented incentive spirometry (VIS), or standard care.Randomization will use a computer-generated sequence with allocation concealment. Blinding of participants is not feasible due to the behavioral nature of the interventions; however, outcome assessors and data analysts will be blinded.Interventions will be delivered independently with no crossover. Measures will minimize contamination, and participants will not be informed of other group protocols. Assessments will be conducted at baseline and post-intervention.Outcomes include acid exposure time, reflux episodes, symptom severity, and esophageal motility parameters.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Include Criteria: * 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. * Willingness and ability to participate in the intervention program, including adherence to training protocols, scheduled follow-up visits, and completion of all required assessments during the study period.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acid exposure time (AET) | The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Esophageal Sphincter (LES) Resting Pressure | Baseline to 6 weeks after intervention | Lower esophageal sphincter resting pressure will be measured using high-resolution manometry (HRM); unit: mmHg |
| Change in Integrated Relaxation Pressure (IRP) | Baseline to 6 weeks after intervention | Integrated relaxation pressure will be assessed using high-resolution manometry (HRM); unit: mmHg. |
| Change in Distal Contractile Integral (DCI) | Baseline to 6 weeks after intervention | Distal contractile integral will be measured using high-resolution manometry (HRM); unit: mmHg·cm·s |
| Change in Distal Latency (DL) | Baseline to 6 weeks after intervention | Distal latency will be assessed using high-resolution manometry (HRM); unit :seconds |
| Change in Reflux Symptom Index (RSI) Score | Baseline to 6 weeks after intervention | 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. |
| Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description | Baseline to 6 weeks after intervention | 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. |
| Change in DeMeester Score | Baseline to 6 weeks after intervention | 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. |
| Mean Nocturnal Baseline Impedance( MNBI) | Baseline to 6 weeks after intervention | 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) |
| Change in Symptom Index (SI) | Baseline to 6 weeks after intervention | 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:% |
| Symptom Sensitivity Index (SSI) | Baseline to 6 weeks after intervention | 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:% |
| Change in Symptom Association Probability (SAP) | Baseline to 6 weeks after intervention | 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:% |
Countries
Taiwan
Contacts
CONTACTKun-Chin Chou, MD
CONTACTShu-Ju Tu, NP, MSN/ PHD Candidate
Outcome results
None listed