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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group IMT | Experimental | inspiratory muscle training (IMT) |
|
| group IMT +TM | Experimental | inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT) |
|
| group placebo | Placebo Comparator | a simulated treatment protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| pressure at the gastroesophageal junction | esophageal manometry | Pre-intervention and after 8 weeks of intervention. |
| number of reflux episodes | impedance-pH monitoring | Pre-intervention and after 8 weeks of intervention. |
| reflux symptoms | Gastroesophageal Reflux Disease Symptom Questionnaire | Pre-intervention and after 8 weeks of intervention. |
| acid exposure time | impedance-pH monitoring | Pre-intervention and after 8 weeks of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| diaphragmatic mobility and thickness | ultrasound | Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention. |
| respiratory muscle strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HELENA ROCHA, Msc | Contact | 55 81 2126-8492 | hmr.fisio@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Pernambuco | Recife | Pernambuco | 50670-901 | Brazil |
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| 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. |
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| 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. |
|
manovacuometry
| 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 variability | heart rate monitor | Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention. |
| diaphragmatic thickness | ultrasound | Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention. |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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