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NCT Number: NCT07584096

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir University of Economics

Izmir, Balçova, 35330, Turkey (Türkiye)

Location contact

Caner Bektaş, MD

SUB_INVESTIGATOR

Nilay Danış, Assoc Prof.

SUB_INVESTIGATOR

Rıdvan Aktan, Assoc Prof.

CONTACT

[email protected]

+902324888579

About this study

The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 4 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 4 weeks of training.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinical diagnosis of NERD,
  • No erosive lesions on endoscopy,
  • Presence of reflux symptoms for at least 3 months.

Exclusion criteria

  • 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
  • With a history of gastrointestinal malignancy
  • With infectious or inflammatory gastrointestinal diseases
  • With malabsorption syndrome or gastrointestinal obstruction
  • With a history of major gastrointestinal surgery (including anti-reflux, gastric, or duodenal surgery)
  • With systemic sclerosis or other systemic connective tissue diseases
  • With severe cardiovascular, pulmonary, renal, or hepatic disease
  • With chronic respiratory diseases such as asthma or COPD
  • Having had an acute respiratory tract infection within the past 4 weeks
  • With neuromuscular diseases
  • With active tuberculosis
  • Pregnancy

Treatment and study plan

Inspiratory Muscle Training (IMT)

Device

The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure, measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.

Sham IMT

Device

The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.

Primary outcomes

  1. Symptom Severity

    Time frame: 4 weeks

    The Reflux Disease Questionnaire (RDQ) will be used to measure the severity of clinical symptoms. The RDQ is a 12-item self-report scale that assesses the frequency and severity of upper gastrointestinal symptoms over the past week. Each item is rated on a Likert scale from 0 to 5, and the total score is calculated as the average of the relevant items. A higher score indicates more severe symptoms.

Secondary outcomes

  1. Inspiratory Muscle Strength

    Time frame: 4 weeks

    The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).

  2. Gastroesophageal Reflux Disease-Related Quality of Life

    Time frame: 4 weeks

    The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) will be used. The questionnaire will be evaluated based on the total score, with a higher score indicating poorer quality of life.

  3. Change in Diagnostic Symptom Score

    Time frame: 4 weeks

    The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) will be used to assess changes in diagnostic symptom scores. A high score indicates severe symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Nilay Danış, Assoc Prof.

CONTACT

[email protected]

+90 2324123704

Rıdvan Aktan, Assoc Prof.

CONTACT

[email protected]

+905453318172

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Registry information

Official study title

Effect of Inspiratory Muscle Training on Clinical Symptom Severity and Quality of Life in Patients With Non-erosive Reflux Disease: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 13, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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