EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES IN INDIVIDUALS WITH GERD

Официальное название

EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES FOR THE LOWER ESOPHAGEAL SPHINCTER AND DIAPHRAGMATIC RELEASE IN INDIVIDUALS WITH GASTROESOPHAGEAL REFLUX DISEASE: A RANDOMIZED CLINICAL TRIAL

Обзор

The objective of this clinical trial is to investigate the efficacy of inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT) in patients with Gastroesophageal Reflux Disease (GERD). The main questions it aims to answer are: 1. If the combination of IMT, DRT, and MTLES can improve GERD symptoms and patients' quality of life. 2. If the home-based IMT protocol, with weekly adjustments, and the manual techniques applied twice a week can have a positive impact on various clinical measures, such as pressure at the lower esophageal sphincter, reflux episodes, and quality of life. The researchers will compare three groups: Group 1 (IMT), Group 2 (IMT + DRT + MTLES), and Group 3 (control, sham), to see if the group receiving IMT combined with DRT and MTLES shows greater improvements compared to the control group. Participants will perform inspiratory muscle training at home, following a protocol adjusted weekly, and will receive manual techniques twice a week.

Подробное описание

The IMT protocol will be performed at home with a load set at 50% of maximal inspiratory pressure (MIP) and adjusted weekly, while manual techniques will be applied twice a week at LACAP. Outcomes include mean pressure at the gastroesophageal junction (esophageal manometry), number of reflux episodes and acid exposure time (impedance-pH monitoring), diaphragmatic mobility and thickness (ultrasound), respiratory muscle strength (manovacuometry), heart rate variability (heart rate monitor), and reflux symptoms and quality of life (questionnaires). It is expected that the combination of IMT, DRT, and MTLES will improve GERD symptoms and positively impact patients' quality of life, providing an effective and less invasive alternative compared to conventional interventions.

Вмешательства

• Процедура inspiratory muscle training
  Volunteers allocated to the Sham group will receive proton pump inhibitor medication at a standard dose of 20 mg Participants will perform home-based IMT with a moderate load set at 50% of maximal inspiratory pressure (PImáx), adjusted weekly during in-person sessions at LACAP-UFPE. Training will use the Powerbreathe® Classic Light device, provided to participants for the study duration. The protocol includes three cycles of 10 explosive respiratory incursions, with one-minute rest intervals, pe
• Процедура inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)
  Volunteers allocated to the group will receive proton pump inhibitor medication at a standard dose of 20 mg. The IMT protocol will be the same as in Group 1. Intervention: IMT Combined with Manual Techniques (MTLES \& DRT) The IMT protocol follows Group 1. DRT (Rocha et al., 2015) involves manual traction during inspiration and deepened contact during expiration, applied in two sets of ten deep breaths. MTLES (Eguaras et al., 2019) is performed with the patient seated, applying epigastric press
• Процедура Controle
  Volunteers allocated to the Sham group will receive proton pump inhibitor medication at a standard dose of 20 mg, as prescribed for other participants. They will undergo a simulated treatment protocol, including inspiratory muscle training (IMT) without load to mimic device use and manual techniques where the therapist places hands on the intervention area without performing actual manipulation.

Первичные конечные точки

• pressure at the gastroesophageal junction [Срок оценки: Pre-intervention and after 8 weeks of intervention.]
• number of reflux episodes [Срок оценки: Pre-intervention and after 8 weeks of intervention.]
• reflux symptoms [Срок оценки: Pre-intervention and after 8 weeks of intervention.]
• acid exposure time [Срок оценки: Pre-intervention and after 8 weeks of intervention.]

Вторичные конечные точки (4)

• diaphragmatic mobility and thickness [Срок оценки: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.]
• respiratory muscle strength [Срок оценки: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.]
• heart rate variability [Срок оценки: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.]
• diaphragmatic thickness [Срок оценки: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.]

Критерии участия

Критерии включения

• Individuals diagnosed with gastroesophageal reflux disease (GERD)
• using 20 mg of proton pump inhibitors (PPIs).

Критерии исключения

• Individuals with a hiatal hernia >3 cm,
• chronic lung diseases (chronic obstructive pulmonary disease and interstitial lung diseases)
• severe heart diseases,
• history of previous abdominal and/or thoracic surgeries, rib fractures within the past year,
• severe osteoporosis
• BMI >30 kg/m²

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Universidade Federal de Pernambuco — Recife

Идентификаторы

NCT: NCT06871163 · DRGE_TMI_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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