Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
inspiratory muscle training (IMT), diaphragmatic release, manual techniques for the lower esophageal sphincter
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.
Interventions
PROCEDUREinspiratory muscle training
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.
PROCEDUREinspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)
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.
PROCEDUREControle
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.
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acid exposure time | Pre-intervention and after 8 weeks of intervention. | impedance-pH monitoring |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Brazil
Contacts
Primary ContactHELENA ROCHA, Msc
Outcome results
None listed