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

NCT06871163 | Not Yet Recruiting

• 1 other identifier: DRGE_TMI_2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.If the combination of IMT, DRT, and MTLES can improve GERD symptoms and patients' quality of life.
2. 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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

inspiratory muscle training (IMT); diaphragmatic release; manual techniques for the lower esophageal sphincter

Outcome Measures

Primary Outcomes (4)

• pressure at the gastroesophageal junction

  esophageal manometry

  Pre-intervention and after 8 weeks of intervention.

• number of reflux episodes

  impedance-pH monitoring

  Pre-intervention and after 8 weeks of intervention.

• reflux symptoms

  Gastroesophageal Reflux Disease Symptom Questionnaire

  Pre-intervention and after 8 weeks of intervention.

• acid exposure time

  impedance-pH monitoring

  Pre-intervention and after 8 weeks of intervention.

Secondary Outcomes (4)

• diaphragmatic mobility and thickness

  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

  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

  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

  Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.

Study Arms (3)

group IMT

EXPERIMENTAL

inspiratory muscle training (IMT)

Procedure: inspiratory muscle training

group IMT +TM

EXPERIMENTAL

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

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

group placebo

PLACEBO COMPARATOR

a simulated treatment protocol

Procedure: Controle

Interventions

inspiratory muscle training PROCEDURE

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, performed twice daily for eight weeks. Participants will record perceived exertion (Borg scale) and any occurrences in a training log.

group IMT

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

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 pressure to access the lower esophageal sphincter through coordinated flexion-inspiration and extension-expiration for 5 minutes.

group IMT +TM

Controle PROCEDURE

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.

group placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

HELENA ROCHA, Msc

CONTACT

55 81 2126-8492; hmr.fisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

BR (1)