Volume-Oriented Incentive Spirometry-Assisted Diaphragmatic Breathing Exercise for Functional Heartburn or Reflux Hypersensitivity (VISDBE)
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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shu-Ju Tu, NP, PHD Candidate
- Telefonnummer: 7591 +88647238595
- E-post: 79610@cch.orh.tw
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Aktiv komparator: Usual Care
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
|
Participants will receive standard pharmacological treatment and lifestyle modification education without structured diaphragmatic breathing exercise.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Score
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CCH-IRB-260526
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