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

NCT07706101 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-07-15

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

standard pharmacological treatment with lifestyle modification education

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

Sponsors & Collaborators

  • Changhua Christian Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2028-04-30
Completion
2028-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706101 on ClinicalTrials.gov