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

Not Applicable

Not yet recruiting

• Conditions: Gastroesophageal Reflux Disease (GERD)

• Registration Number: NCT06871163
• Lead Sponsor: Universidade Federal de Pernambuco

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. 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-04
• Primary Completion: 2026-04
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pressure at the gastroesophageal junction	Pre-intervention and after 8 weeks of intervention.	esophageal manometry
number of reflux episodes	Pre-intervention and after 8 weeks of intervention.	impedance-pH monitoring
reflux symptoms	Pre-intervention and after 8 weeks of intervention.	Gastroesophageal Reflux Disease Symptom Questionnaire
acid exposure time	Pre-intervention and after 8 weeks of intervention.	impedance-pH monitoring

Secondary Outcome Measures

Name	Time	Method
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.	manovacuometry
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.	heart rate monitor
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.	ultrasound
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.	ultrasound

Trial Locations

Locations (1)

Universidade Federal de Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil