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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Inspiratory Muscle Training (IMT)
  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.
• Устройство Sham IMT
  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.

Первичные конечные точки

• Symptom Severity [Срок оценки: 4 weeks]

Вторичные конечные точки (3)

• Inspiratory Muscle Strength [Срок оценки: 4 weeks]
• Gastroesophageal Reflux Disease-Related Quality of Life [Срок оценки: 4 weeks]
• Change in Diagnostic Symptom Score [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Izmir University of Economics — Izmir

Публикации

• 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. PMID 34325496
• 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. PMID 41579192
• 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. PMID 19262545
• 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. PMID 20535321

Идентификаторы

NCT: NCT07584096 · E-97429853-050.04- 124388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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