Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity
82 participantsStarted 2026-08-20
Plain-language summary
The goal of this pilot randomized controlled trial is to determine whether volume-oriented incentive spirometry-assisted diaphragmatic breathing exercise (VIS-assisted DBE) can improve reflux-related symptoms and health-related quality of life in adults with functional heartburn (FH) or reflux hypersensitivity (RH).
The main questions it aims to answer are:
Does VIS-assisted DBE reduce reflux-related symptoms compared with usual care? Does VIS-assisted DBE improve health-related quality of life compared with usual care? Researchers will compare VIS-assisted DBE plus usual care with usual care alone to determine whether the intervention provides additional benefits in symptom relief and quality of life.
Participants will:
Complete baseline clinical evaluations and symptom questionnaires. Be randomly assigned to either the VIS-assisted DBE group or the usual care group.
Receive either VIS-assisted diaphragmatic breathing exercises twice daily for 20 minutes over a 4-week period in addition to usual care, or usual care alone.
Complete follow-up assessments after the 4-week intervention, including symptom and quality-of-life questionnaires
Who can participate
Age range
20 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria:
* Adults aged 20 to 100 years.
* Diagnosis of functional heartburn (FH) or reflux hypersensitivity (RH) according to the Rome IV criteria.
* Normal upper gastrointestinal endoscopy without evidence of erosive esophagitis, Barrett's esophagus, or hiatal hernia.
* Normal esophageal motility on high-resolution manometry (HRM) according to the Chicago Classification Version 4.0.
* Diagnosis of FH or RH confirmed by 24-hour multichannel intraluminal impedance-pH (MII-pH) monitoring according to the Rome IV criteria and Lyon Consensus 2.0.
* Able and willing to perform diaphragmatic breathing exercises and comply with study procedures.
* Able to provide written informed consent.
* Exclusion Criteria:
* Pregnant or breastfeeding women.
* Severe cardiopulmonary dysfunction or chronic respiratory disease.
* Inability to perform diaphragmatic breathing exercises or comply with the study protocol and scheduled follow-up visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score