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Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity
Sponsor: Changhua Christian Hospital
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
Official title: Effect of Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise in Patients With Functional Heartburn or Reflux Hypersensitivity: A Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
20 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2026-08-20
Completion Date
2028-07-30
Last Updated
2026-07-15
Healthy Volunteers
No
Interventions
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.
standard pharmacological treatment with lifestyle modification education
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.