Breathing muscle training for gastroesophageal reflux (GERD)
The Effect of Inspiratory Muscle Training on Inspiratory Strength in People With Gastroesophageal Reflux Disease.
This trial will test whether a 3-month inspiratory muscle training program helps adults with GERD strengthen their breathing muscles and reduce reflux symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of West Attica Academic / other |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT07131397 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, two-arm parallel equivalence trial will assign 30 adults with diagnosed GERD or an RDQ score >8 to either active inspiratory muscle training (IMT) or a sham IMT control. The active group will complete 36 sessions of tapered flow resistive loading starting at 40% of maximal inspiratory pressure with weekly increases, while the sham group will receive 36 sessions at a constant low resistance (7 cmH2O). Outcomes measured at baseline, immediately after the 3-month program, and at 6-month follow-up include maximal inspiratory pressure (MIP), dynamic inspiratory power (s-index), GERD symptom frequency (RDQ), and reflux-related quality of life. The trial tests whether targeted respiratory muscle training can improve inspiratory strength and patient-reported reflux symptoms compared with sham therapy.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of GERD or an RDQ score above 8 who can attend in-person sessions at the University of West Attica and do not meet exclusion criteria are ideal candidates.
Not a fit: People with prior stomach or duodenal surgery, systemic connective tissue disease, active tuberculosis, pregnancy, significant mental disorders, or those without diaphragm weakness may be unlikely to benefit or are excluded.
Why it matters
Potential benefit: If effective, IMT could offer a low-risk, noninvasive way to strengthen the diaphragm, reduce reflux symptoms, and improve quality of life for people with GERD.
How similar studies have performed: Small prior studies and physiological data suggest inspiratory muscle training can improve diaphragmatic strength and sometimes reduce reflux symptoms, but high-quality randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: people diagnosed with GERD or had a score of more than 8 on the Gastroesophageal Reflux Disease Questionnaire Exclusion Criteria: systemic connective tissue diseases, mental disorders, stomach or duodenal surgery, tuberculosis, pregnancy
Where this trial is running
Athens, Attica
- University of West Attica — Athens, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Irini Patsaki, PhD
- Email: ipatsaki@uniwa.gr
- Phone: +306942064363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.