Functional Heartburn (FH), Reflux Hypersensitivity
Conditions
Keywords
Functional Heartburn, Reflux Hypersensitivity, Volume-Oriented Incentive Spirometry, Diaphragmatic Breathing Exercise, Disorders of Gut-Brain Interaction, Autonomic Nervous System, Quality of Life
Brief 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
Detailed description
Functional heartburn (FH) and reflux hypersensitivity (RH) are disorders of gut-brain interaction characterized by persistent reflux-related symptoms despite the absence of significant esophageal acid exposure or structural abnormalities. Although proton pump inhibitors are widely used for reflux-related disorders, many patients with FH and RH continue to experience persistent symptoms, resulting in reduced health-related quality of life. Current evidence suggests that altered esophageal sensory processing, autonomic nervous system dysfunction, and impaired gut-brain axis regulation contribute to symptom generation in these disorders. Diaphragmatic breathing exercise has emerged as a promising non-pharmacological intervention that may improve diaphragmatic function, enhance vagal activity, and reduce reflux-related symptoms. Volume-oriented incentive spirometry (VIS) provides visual feedback during breathing training and may improve the consistency and effectiveness of diaphragmatic breathing. However, evidence regarding the therapeutic effects of VIS-assisted diaphragmatic breathing exercise in patients with FH or RH remains limited. This prospective, parallel-group, pilot randomized controlled trial is designed to evaluate the clinical effectiveness of VIS-assisted diaphragmatic breathing exercise in adults with FH or RH. Participants will be randomly assigned to receive either VIS-assisted diaphragmatic breathing exercise in addition to usual care or usual care alone. The study will assess whether the intervention improves reflux-related symptoms and health-related quality of life compared with usual care. The findings of this study are expected to provide preliminary evidence regarding the feasibility and potential clinical benefits of VIS-assisted diaphragmatic breathing exercise as an adjunctive non-pharmacological treatment for functional heartburn and reflux hypersensitivity, and to support the design of future larger randomized controlled trials.
Interventions
BEHAVIORALVolume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise
Participants will perform diaphragmatic breathing exercises assisted by a volume-oriented incentive spirometer twice daily for 20 minutes per session over a 4-week intervention period under standardized instructions.
BEHAVIORALstandard pharmacological treatment with lifestyle modification education
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
Sponsors
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two parallel study arms using block randomization.
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | From baseline to Week 4 | The primary outcome is the change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) score from baseline to the end of the 4-week intervention. The GERDQ is a validated patient-reported questionnaire used to assess the frequency and severity of reflux-related symptoms. Higher scores indicate more severe symptoms. The change in GERDQ score will be compared between the intervention and usual care groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score | From baseline to Week 4 | The secondary outcome is the change in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score from baseline to the end of the 4-week intervention. The GERD-HRQL questionnaire evaluates the impact of reflux-related symptoms on health-related quality of life. Higher scores indicate poorer health-related quality of life. The change in GERD-HRQL score will be compared between the intervention and usual care groups |
| Change in Reflux Disease Questionnaire (RDQ) Score | From baseline to Week 4 | The secondary outcome is the change in the Reflux Disease Questionnaire (RDQ) score from baseline to the end of the 4-week intervention. The RDQ is a validated patient-reported questionnaire that assesses the frequency and severity of reflux-related symptoms. Higher scores indicate more severe symptoms. The change in RDQ score will be compared between the intervention and usual care groups. |
Contacts
CONTACTShu-Ju Tu, NP, PHD Candidate
Outcome results
None listed