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NCT Number: NCT06871163

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

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. pressure at the gastroesophageal junction

    Time frame: Pre-intervention and after 8 weeks of intervention.

    esophageal manometry

  2. number of reflux episodes

    Time frame: Pre-intervention and after 8 weeks of intervention.

    impedance-pH monitoring

  3. reflux symptoms

    Time frame: Pre-intervention and after 8 weeks of intervention.

    Gastroesophageal Reflux Disease Symptom Questionnaire

  4. acid exposure time

    Time frame: Pre-intervention and after 8 weeks of intervention.

    impedance-pH monitoring

Secondary outcomes

  1. diaphragmatic mobility and thickness

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

    ultrasound

  2. respiratory muscle strength

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

    manovacuometry

  3. heart rate variability

    Time frame: 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

  4. diaphragmatic thickness

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

    ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

HELENA ROCHA, Msc

CONTACT

[email protected]

55 81 2126-8492

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study 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

Acronym: GERD

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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