GERDGERDNCT07544433
Diaphragmatic Training on GERD
A study testing Volume-oriented incentive spirometry and Diaphragmatic breathing exercise in people with GERD and Diaphragmatic Training, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- GERD, Diaphragmatic Training
- What is being tested?
- Volume-oriented incentive spirometry and Diaphragmatic breathing exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, Changhua County, 50006
About this study
Official title: Diaphragmatic Training for Gastroesophageal Reflux Disease: A Randomized Controlled Trial Comparing the Effects of Diaphragmatic Breathing Exercise and Incentive Spirometry Training on Esophageal Dynamics and Quality of Life
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
- Conditions
- GERD, Diaphragmatic Training
- Being tested
- Volume-oriented incentive spirometry, Diaphragmatic breathing exercise, Usual Care Group
- Keywords
- GERD, incentive spirometry, esophageal dynamics, quality of life, Diaphragmatic training, diaphragmatic breathing exercise, incentive spirometry training
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-oriented incentive spirometryDevice
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 exerciseBehavioural
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
Usual Care GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Volume-Oriented Incentive Spirometry (VIS) | Experimental | 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 Receives: Device: Volume-oriented incentive spirometry |
| Diaphragmatic breathing exercises (DBE) | Experimental | 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. Receives: Behavioral: Diaphragmatic breathing exercise |
| Usual Care (Control) | Active comparator | 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. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period
Secondary outcomes (12)
Change in Lower Esophageal Sphincter (LES) Resting Pressure
Lower esophageal sphincter resting pressure will be measured using high-resolution manometry (HRM); unit: mmHg
Measured: 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.
Measured: 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
Measured: Baseline to 6 weeks after intervention
Change in Distal Latency (DL)
Distal latency will be assessed using high-resolution manometry (HRM); unit :seconds
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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:%
Measured: 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:%
Measured: 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:%
Measured: Baseline to 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start4 Mar 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ching Chou, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544433
- Sponsor's protocol ID
- CCH-251257
- Acronym
- GERD
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Training for Gastroesophageal Reflux Disease: A Randomized Controlled Trial Comparing the Effects of Diaphragmatic Breathing Exercise and Incentive Spirometry Training on Esophageal Dynamics and Quality of Life
- ClinicalTrials.gov ID
- NCT07544433
- Acronym / sponsor ID
- GERD / CCH-251257
- Conditions
- GERD, Diaphragmatic Training
- Keywords
- GERD, incentive spirometry, esophageal dynamics, quality of life, Diaphragmatic training, diaphragmatic breathing exercise, incentive spirometry training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Volume-Oriented Incentive Spirometry (VIS) | Experimental | Device: Volume-oriented incentive spirometryParticipants 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 |
| Diaphragmatic breathing exercises (DBE) | Experimental | Behavioral: Diaphragmatic breathing exerciseParticipants 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. |
| Usual Care (Control) | Active comparator | Other: Usual Care GroupParticipants 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-oriented incentive spirometryVolume-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. | Device | Volume-Oriented Incentive Spirometry (VIS) |
| Diaphragmatic breathing exerciseDiaphragmatic 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 | Behavioural | Diaphragmatic breathing exercises (DBE) |
| Usual Care GroupParticipants 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. | Other | Usual Care (Control) |
Primary outcome
Acid exposure time (AET)
Time frame: 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
12 secondary outcomes
Change in Lower Esophageal Sphincter (LES) Resting Pressure
Time frame: Baseline to 6 weeks after intervention
Change in Integrated Relaxation Pressure (IRP)
Time frame: Baseline to 6 weeks after intervention
Change in Distal Contractile Integral (DCI)
Time frame: Baseline to 6 weeks after intervention
Change in Distal Latency (DL)
Time frame: Baseline to 6 weeks after intervention
Change in Distal Contractile Integral (DCI)
Time frame: Baseline to 6 weeks after intervention
Change in Reflux Symptom Index (RSI) Score
Time frame: Baseline to 6 weeks after intervention
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Description
Time frame: Baseline to 6 weeks after intervention
Change in DeMeester Score
Time frame: Baseline to 6 weeks after intervention
Mean Nocturnal Baseline Impedance( MNBI)
Time frame: Baseline to 6 weeks after intervention
Change in Symptom Index (SI)
Time frame: Baseline to 6 weeks after intervention
Symptom Sensitivity Index (SSI)
Time frame: Baseline to 6 weeks after intervention
Change in Symptom Association Probability (SAP)
Time frame: Baseline to 6 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume-oriented incentive spirometry and Diaphragmatic breathing exercise in people with GERD and Diaphragmatic Training, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun-Chin Chou, MD (+886-4-723-8595 ext. 5501, 84798@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acid exposure time (AET) (time frame: The outcome is defined as the change in these parameters from baseline to the end of the 6-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.