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

Universidade Federal de Pernambuco

Status: Not yet enrolling

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Procedure: inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT); Procedure: inspiratory muscle training; Procedure: Controle

Study type: Interventional

Funder types: Other

Identifiers

NCT06871163

DRGE_TMI_2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

group IMT

Experimental group

Description:

inspiratory muscle training (IMT)

Treatment:

Procedure: inspiratory muscle training

group IMT +TM

Experimental group

Description:

inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)

Treatment:

Procedure: inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)

group placebo

Placebo Comparator group

Description:

a simulated treatment protocol

Treatment:

Procedure: Controle