Incentive SpirometerNCT07179250
Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease
A study testing Volume-Oriented Incentive Spirometer and Diaphragmatic Breathing Exercise (DBE) in people with Incentive Spirometer and Diaphragmatic Breathing, run by Changhua Christian Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Incentive Spirometer, Diaphragmatic Breathing, Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Volume-Oriented Incentive Spirometer and Diaphragmatic Breathing Exercise (DBE)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2026
- 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
- Adults aged 20 to 80 years
- Endoscopic finding of reflux esophagitis (LA grade A) with proton pump inhibitor (PPI) use > 2 months, or 24-hour pH monitoring showing acid exposure time (AET) > 6%, or endoscopic diagnosis of reflux esophagitis LA grade B or higher
- Willingness to comply with the full training and follow-up protocol
Who cannot join
- Pregnant or breastfeeding women
- History of anti-reflux surgery
- Severe cardiopulmonary dysfunction or respiratory disease
- Inability to perform the training exercises or attend follow-up visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease: A Parallel Randomized Controlled Trial
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:
Read more
- 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
Read the 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.
- Conditions
- Incentive Spirometer, Diaphragmatic Breathing, Gastroesophageal Reflux Disease (GERD), Breath Exercise
- Being tested
- Volume-Oriented Incentive Spirometer, Diaphragmatic Breathing Exercise (DBE), Usual Care and Education
- Keywords
- GERD, Gastroesophageal Reflux Disease, Acid Reflux, Diaphragmatic Breathing, Breathing Training, Incentive Spirometer, Volume-Oriented Incentive Spirometry, GERDQ, Gastroesophageal Reflux Disease Questionnaire, breath exercise
- 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 SpirometerDevice
Participants in the experimental group will perform volume-oriented incentive spirometry training twice daily (morning and evening) for 6 weeks. Each session consists of 10 deep inspirations using the spirometer, with the target volume initially set according to the participant's predicted maximum inspiratory capacity and increased by approximately 5% each week starting from week 2. For each breath, participants inhale to reach the target volume, hold their breath for 3-5 seconds, and then exhale. A rest period of 30-60 seconds is allowed between maneuvers, and the pace is adjusted according to individual tolerance. Training is performed in a seated or semi-recumbent position.
Diaphragmatic Breathing Exercise (DBE)Behavioural
Participants in the control group will perform diaphragmatic breathing exercises twice daily (morning and evening) for 6 weeks. During weeks 1-2, each session consists of 10 breaths per set; from week 3 to week 6, each session consists of 15 breaths per set. The exercise is performed without devices and includes the following sequence: slow inspiration through the nose with abdominal expansion, holding the breath for 5 seconds, followed by exhalation through the mouth with visible abdominal contraction. After each set, participants rest with natural breathing for 1-2 minutes to prevent hyperventilation or diaphragmatic fatigue. Training is conducted in a semi-recumbent position with both hands placed behind the head, focusing on abdominal movement control and breathing rhythm.
Usual Care and EducationBehavioural
Participants in the control group will receive usual clinical care for gastroesophageal reflux disease (GERD) without structured breathing training. At study entry, participants are provided with standardized patient education regarding GERD and lifestyle modification strategies, along with an educational leaflet. No specific posture or breathing exercises are required during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Volume-Oriented Incentive Spirometry (VIS) | Experimental | Participants in this group will perform diaphragmatic breathing exercises twice daily for 6 weeks using a volume-oriented incentive spirometer, in addition to usual care. Assessments will be conducted at baseline and at the end of week 7. Receives: Device: Volume-Oriented Incentive Spirometer |
| Diaphragmatic Breathing Exercises (DBE) | Experimental | In this group will perform standard diaphragmatic breathing exercises twice daily for 6 weeks, in addition to usual care. Assessments will be conducted at baseline and at the end of week 7. Receives: Behavioral: Diaphragmatic Breathing Exercise (DBE) |
| Usual Care (Control) | Placebo comparator | Participants in this group will receive standard clinical management for gastroesophageal reflux disease without structured breathing training. Assessments will be conducted at baseline and at the end of week 7. Receives: Behavioral: Usual Care and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower esophageal sphincter (LES) pressure
LES pressure will be measured using high-resolution manometry (HRM). The mean resting pressure (mmHg) of the LES will be recorded and analyzed to evaluate changes from baseline to week 7 between groups
Measured: Baseline and Week 7
Secondary outcomes (4)
Change in GERD symptom severity measured by GERDQ
GERD-related symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GERDQ), a validated 6-item self-reported instrument. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms. Changes from baseline to week 7 will be compared between groups.
Measured: Baseline and Week 7
Change in the number of reflux episodes within 24 hours
Ambulatory 24-hour pH-impedance monitoring will be used to quantify the total number of gastroesophageal reflux episodes. Differences between baseline and week 7 will be assessed across groups
Measured: Baseline and Week 7
Change in esophageal acid exposure time (AET)
Esophageal acid exposure will be evaluated using 24-hour pH monitoring. AET is defined as the percentage of time with esophageal pH < 4.0 during the 24-hour monitoring period. Changes from baseline to week 7 will be compared
Measured: Baseline and Week 7
Change in the number of effective esophageal peristalsis events
Esophageal motility will be assessed using high-resolution manometry (HRM). The number of effective peristaltic contractions within 24 hours will be recorded. Changes from baseline to week 7 will be analyzed between groups
Measured: Baseline and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incentive SpirometerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial adopts a parallel assignment model with three arms: volume-oriented incentive spirometry (VIS), diaphragmatic breathing exercise (DBE), and usual care (control). Participants are randomized in a 1:1:1 ratio using a computer-generated sequence with allocation concealment through sealed opaque envelopes. The intervention period lasts 6 weeks, and assessments are performed at baseline and week 7. No crossover between groups is planned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Ju Tu, MSN, NP, RN, Principal investigator, Changhua Christian Hospital, Dept. of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179250
- Sponsor's protocol ID
- CCH-IRB-250618
- Other IDs
- CCH-IRB-250618
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic characteristics, baseline clinical data, intervention adherence, and primary and secondary outcome measures (GERDQ scores, LES pressure, 24-hour pH-impedance results, and HRM parameters). No identifiable personal information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease: A Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07179250
- Acronym / sponsor ID
- CCH-IRB-250618
- Conditions
- Incentive Spirometer, Diaphragmatic Breathing, Gastroesophageal Reflux Disease (GERD), Breath Exercise
- Keywords
- GERD, Gastroesophageal Reflux Disease, Acid Reflux, Diaphragmatic Breathing, Breathing Training, Incentive Spirometer, Volume-Oriented Incentive Spirometry, GERDQ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This randomized controlled trial adopts a parallel assignment model with three arms: volume-oriented incentive spirometry (VIS), diaphragmatic breathing exercise (DBE), and usual care (control). Participants are randomized in a 1:1:1 ratio using a computer-generated sequence with allocation concealment through sealed opaque envelopes. The intervention period lasts 6 weeks, and assessments are performed at baseline and week 7. No crossover between groups is planned.
| Arm | Type | Receives |
|---|---|---|
| Volume-Oriented Incentive Spirometry (VIS) | Experimental | Device: Volume-Oriented Incentive SpirometerParticipants in this group will perform diaphragmatic breathing exercises twice daily for 6 weeks using a volume-oriented incentive spirometer, in addition to usual care. Assessments will be conducted at baseline and at the end of week 7. |
| Diaphragmatic Breathing Exercises (DBE) | Experimental | Behavioral: Diaphragmatic Breathing Exercise (DBE)In this group will perform standard diaphragmatic breathing exercises twice daily for 6 weeks, in addition to usual care. Assessments will be conducted at baseline and at the end of week 7. |
| Usual Care (Control) | Placebo comparator | Behavioral: Usual Care and EducationParticipants in this group will receive standard clinical management for gastroesophageal reflux disease without structured breathing training. Assessments will be conducted at baseline and at the end of week 7. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 to 80 years
- Endoscopic finding of reflux esophagitis (LA grade A) with proton pump inhibitor (PPI) use > 2 months, or 24-hour pH monitoring showing acid exposure time (AET) > 6%, or endoscopic diagnosis of reflux esophagitis LA grade B or higher
- Willingness to comply with the full training and follow-up protocol
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- History of anti-reflux surgery
- Severe cardiopulmonary dysfunction or respiratory disease
- Inability to perform the training exercises or attend follow-up 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 SpirometerParticipants in the experimental group will perform volume-oriented incentive spirometry training twice daily (morning and evening) for 6 weeks. Each session consists of 10 deep inspirations using the spirometer, with the target volume initially set according to the participant's predicted maximum inspiratory capacity and increased by approximately 5% each week starting from week 2. For each breath, participants inhale to reach the target volume, hold their breath for 3-5 seconds, and then exhale. A rest period of 30-60 seconds is allowed between maneuvers, and the pace is adjusted according to individual tolerance. Training is performed in a seated or semi-recumbent position. | Device | Volume-Oriented Incentive Spirometry (VIS) |
| Diaphragmatic Breathing Exercise (DBE)Participants in the control group will perform diaphragmatic breathing exercises twice daily (morning and evening) for 6 weeks. During weeks 1-2, each session consists of 10 breaths per set; from week 3 to week 6, each session consists of 15 breaths per set. The exercise is performed without devices and includes the following sequence: slow inspiration through the nose with abdominal expansion, holding the breath for 5 seconds, followed by exhalation through the mouth with visible abdominal contraction. After each set, participants rest with natural breathing for 1-2 minutes to prevent hyperventilation or diaphragmatic fatigue. Training is conducted in a semi-recumbent position with both hands placed behind the head, focusing on abdominal movement control and breathing rhythm. | Behavioural | Diaphragmatic Breathing Exercises (DBE) |
| Usual Care and EducationParticipants in the control group will receive usual clinical care for gastroesophageal reflux disease (GERD) without structured breathing training. At study entry, participants are provided with standardized patient education regarding GERD and lifestyle modification strategies, along with an educational leaflet. No specific posture or breathing exercises are required during the study period. | Behavioural | Usual Care (Control) |
Primary outcome
Change in lower esophageal sphincter (LES) pressure
Time frame: Baseline and Week 7
LES pressure will be measured using high-resolution manometry (HRM). The mean resting pressure (mmHg) of the LES will be recorded and analyzed to evaluate changes from baseline to week 7 between groups
4 secondary outcomes
Change in GERD symptom severity measured by GERDQ
Time frame: Baseline and Week 7
Change in the number of reflux episodes within 24 hours
Time frame: Baseline and Week 7
Change in esophageal acid exposure time (AET)
Time frame: Baseline and Week 7
Change in the number of effective esophageal peristalsis events
Time frame: Baseline and Week 7
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 26 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including demographic characteristics, baseline clinical data, intervention adherence, and primary and secondary outcome measures (GERDQ scores, LES pressure, 24-hour pH-impedance results, and HRM parameters). No identifiable personal information will be included.
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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.
Shu-Ju Tu, MSN, NP, RN principal investigator
Changhua Christian Hospital, Dept. of Gastroenterology
Questions about this trial
What is this clinical trial studying?
A study testing Volume-Oriented Incentive Spirometer and Diaphragmatic Breathing Exercise (DBE) in people with Incentive Spirometer and Diaphragmatic Breathing, run by Changhua Christian Hospital.
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 3 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: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Shu-Ju Tu, MSN, NP, RN (+886-4-723-8595 ext. 7591, 79610@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower esophageal sphincter (LES) pressure (time frame: Baseline and Week 7). 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 26 Sep 2025.