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

NCT ID: NCT01449643

Last Updated: 2011-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-08-31

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

Conditions

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Obesity

Keywords

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Obesity Diaphragm Inspiratory muscular training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IMT Group

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.

Group Type ACTIVE_COMPARATOR

Threshold

Intervention Type DEVICE

Sham Group

Non-training protocol

Group Type SHAM_COMPARATOR

Sham Threshold

Intervention Type DEVICE

Interventions

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Threshold

Intervention Type DEVICE

Sham Threshold

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Lui-s Henrique Sarmento Tenorio

Master's Degree Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria S Brasileiro-Santos, D.Sc

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Locations

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Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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Tenorio LH, Santos AC, Camara Neto JB, Amaral FJ, Passos VM, Lima AM, Brasileiro-Santos Mdo S. The influence of inspiratory muscle training on diaphragmatic mobility, pulmonary function and maximum respiratory pressures in morbidly obese individuals: a pilot study. Disabil Rehabil. 2013;35(22):1915-20. doi: 10.3109/09638288.2013.769635. Epub 2013 May 7.

Reference Type DERIVED
PMID: 23651130 (View on PubMed)

Other Identifiers

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CAAE-0280.0.172.000-10

Identifier Type: -

Identifier Source: org_study_id