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

October 28, 2011 updated by: Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Universidade Federal de Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 40 kg/m²
  • Absence of acute or chronic lung disease

Exclusion Criteria:

  • Acute or chronic inflammatory process
  • Thyroid disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Device: Threshold
SHAM_COMPARATOR: Sham Group
Non-training protocol
Device: Sham Threshold

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function test
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Investigators

  • Principal Investigator: Maria S Brasileiro-Santos, D.Sc, Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (ESTIMATE)

October 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2011

Last Update Submitted That Met QC Criteria

October 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE-0280.0.172.000-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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