The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese

Study Overview
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Brief Summary
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The purpose of this study is whether an inspiratory muscle training protocol would be associated with an improvement in of the diaphragm mobility, an increase in pulmonary function values , gain strength and endurance of respiratory muscles and improving quality of life.

Detailed Description
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Few studies have investigated the effects of an inspiratory muscle training in obese patients on the diaphragmatic mobility and thickness. Obesity, especially morbid, triggers changes in the respiratory system, which can affect the work activities and daily life of individuals with this multifactorial syndrome. These functional changes in mechanical ventilation may be linked to weakness and poor respiratory muscle strength, so by promoting rehabilitation of these muscles can minimize the losses that come with obesity

Official Title
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The Influence of Inspiratory Muscular Training on Diaphragmatic Mobility, Lung Function and Quality of Life in Obese Individuals

Conditions
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Obesity

Intervention / Treatment
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* Device: Threshold
* Device: Sham Threshold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 40 kg/m² Absence of acute or chronic lung disease Exclusion Criteria: Acute or chronic inflammatory process Thyroid disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IMT Group<br>Threshold IMT provides consistent and specific pressure for inspiratory muscle strength and endurance training, regardless of how quickly or slowly patients breathe. This device incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting (in cm H20). When patients inhale through Threshold IMT, a spring-loaded valve provides a resistance that exercises respiratory muscles through conditioning. | Device: Threshold<br> <br> |
| Sham Comparator: Sham Group<br>Non-training protocol | Device: Sham Threshold<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound evaluation of the diaphragm mobility | Compare and correlate diapgragm excursion with pulmonary function. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diaphragm, Inspiratory muscular training