Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Reflux Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIzmir University of Economics

About this trial

The goal of this clinical trial is to learn if inspiratory muscle training (IMT) works to treat on clinical symptom severity and quality of life in patients with Non-erosive reflux disease (NERD). The main questions it aims to answer are:

Does drug IMT lower the clinical symptom severity ? Does drug IMT improve quality of life? Researchers will compare high intensity IMT to a sham-IMT (a IMT device with no resistance) to see if IMT lower the clinical symptom severity and improve improve quality of life.

Participants will perform the following protocol:

The IMT protocol will consist of home-based high-intensity training using a Threshold IMT device: two sets of 30 breaths with a 1-minute rest, twice daily for 4 weeks. The study group will train at 60% of baseline maximum inspiratory pressure (MIP), with weekly adjustments based on modified Borg scores (4-6), while the control group will perform sham IMT without resistance.

Eligibility criteria

Qualifiers

A clinical diagnosis of NERD,

No erosive lesions on endoscopy,

Presence of reflux symptoms for at least 3 months.

Disqualifiers

Current use of proton pump inhibitors (PPIs) or failure to complete a minimum 2-week washout period before enrollment.

With known gastroduodenal ulcers

Diagnosed with erosive esophagitis

With hiatal hernia

Trial design

Treatments tested in this trial

  • Inspiratory Muscle Training (IMT)
  • Sham IMT

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators