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

ConditionGastroesophageal Reflux Disease (GERD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorUniversidade Federal de Pernambuco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals diagnosed with gastroesophageal reflux disease (GERD)

using 20 mg of proton pump inhibitors (PPIs).

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • inspiratory muscle training

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: group IMTExperimental treatment 1 intervention
Group B: group IMT +TMExperimental treatment 1 intervention
Group C: group placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

pressure at the gastroesophageal junction

esophageal manometry

Time frame
Pre-intervention and after 8 weeks of intervention.
2

number of reflux episodes

impedance-pH monitoring

Time frame
Pre-intervention and after 8 weeks of intervention.
3

reflux symptoms

Gastroesophageal Reflux Disease Symptom Questionnaire

Time frame
Pre-intervention and after 8 weeks of intervention.
4

acid exposure time

impedance-pH monitoring

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

Secondary outcomes

1

diaphragmatic mobility and thickness

ultrasound

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.
2

respiratory muscle strength

manovacuometry

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.
3

heart rate variability

heart rate monitor

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.
4

diaphragmatic thickness

ultrasound

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal de Pernambuco

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: