Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity (VISDBE)

July 10, 2026 updated by: Kun-Ching Chou, Changhua Christian Hospital

Effect of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise in Patients With Functional Heartburn or Reflux Hypersensitivity: A Pilot Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shu-Ju Tu, NP, PHD Candidate
  • Phone Number: 7591 +88647238595
  • Email: 79610@cch.orh.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS)
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.
Behavioral: Volume-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.
Active Comparator: Usual Care
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
Behavioral: standard pharmacological treatment with lifestyle modification education
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score
Time Frame: 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
From baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score
Time Frame: 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
From baseline to Week 4
Change in Reflux Disease Questionnaire (RDQ) Score
Time Frame: 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.
From baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCH-IRB-260526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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