Clinical trial NCT06871163: EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES IN INDIVIDUALS WITH GERD
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: inspiratory muscle training (IMT)
diaphragmatic release
manual techniques for the lower esophageal sphincter
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pressure at the gastroesophageal junction
timeFrame: Pre-intervention and after 8 weeks of intervention.
measure: number of reflux episodes
timeFrame: Pre-intervention and after 8 weeks of intervention.
measure: reflux symptoms
timeFrame: Pre-intervention and after 8 weeks of intervention.
measure: acid exposure time
timeFrame: Pre-intervention and after 8 weeks of intervention.
Secondary outcomes:
measure: diaphragmatic mobility and thickness
timeFrame: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.
measure: respiratory muscle strength
timeFrame: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.
measure: heart rate variability
timeFrame: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.
measure: diaphragmatic thickness
timeFrame: Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References: