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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Patients who will perform inspiratory muscle training (IMT) with %60 loading |
|
| Sham Group | Sham Comparator | Patients who will perform Sham IMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Muscle Strength | 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). | 4 weeks |
| Gastroesophageal Reflux Disease-Related Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rıdvan Aktan, Assoc Prof. | Contact | +905453318172 | ridvanaktan@gmail.com | |
| Nilay Danış, Assoc Prof. | Contact | +90 2324123704 | nilaydanis17@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rıdvan Aktan, Assoc Prof. | İzmir University of Economics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir University of Economics | Izmir | Balçova | 35330 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34325496 | Background | Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30. | |
| 41579192 | Background | Aktan R, Yakit Yesilyurt S, Ozalevli S, Sonbahar AE. Effects of Home-Based, Telerehabilitation-Assisted High-Intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women with Stress Urinary Incontinence: A Pilot Randomized Controlled Trial. Int Urogynecol J. 2026 Jun;37(6):1679-1688. doi: 10.1007/s00192-026-06517-7. Epub 2026 Jan 24. |
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| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
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This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
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|
| 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. |
|
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. |
| 4 weeks |
| Change in Diagnostic Symptom Score | The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) will be used to assess changes in diagnostic symptom scores. A high score indicates severe symptoms. | 4 weeks |
| 19262545 | Background | Fass R. Proton pump inhibitor failure--what are the therapeutic options? Am J Gastroenterol. 2009 Mar;104 Suppl 2:S33-8. doi: 10.1038/ajg.2009.50. |
| 20535321 | Background | Hershcovici T, Fass R. Nonerosive Reflux Disease (NERD) - An Update. J Neurogastroenterol Motil. 2010 Jan;16(1):8-21. doi: 10.5056/jnm.2010.16.1.8. Epub 2010 Jan 31. |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |