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

NCT07706101 | Not Yet Recruiting

• 1 other identifier: CCH-IRB-260526
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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

Conditions

Functional Heartburn (FH); Reflux Hypersensitivity

Keywords

Functional Heartburn; Reflux Hypersensitivity; Volume-Oriented Incentive Spirometry; Diaphragmatic Breathing Exercise; Disorders of Gut-Brain Interaction; Autonomic Nervous System; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score

  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 Outcomes (2)

• Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score

  From baseline to Week 4

• Change in Reflux Disease Questionnaire (RDQ) Score

  From baseline to Week 4

Study Arms (2)

Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS)

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.

Behavioral: standard pharmacological treatment with lifestyle modification education

Interventions

Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise BEHAVIORAL

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.

Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise Group (VIS)

standard pharmacological treatment with lifestyle modification education BEHAVIORAL

Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.

Usual Care

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Central Study Contacts

Shu-Ju Tu, NP, PHD Candidate

CONTACT

+88647238595; 79610@cch.orh.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel study arms using block randomization.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07