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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449643
First Posted: October 10, 2011
Last Update Posted: October 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco
  Purpose
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.

Condition Intervention
Obesity Device: Threshold Device: Sham Threshold

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Influence of Inspiratory Muscular Training on Diaphragmatic Mobility, Lung Function and Quality of Life in Obese Individuals

Further study details as provided by Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Ultrasound evaluation of the diaphragm mobility [ Time Frame: 3 months ]
    Compare and correlate diapgragm excursion with pulmonary function.


Secondary Outcome Measures:
  • Pulmonary function test [ Time Frame: 3 months ]

Enrollment: 14
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute or chronic inflammatory process
  • Thyroid disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449643


Locations
Brazil
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Principal Investigator: Maria S Brasileiro-Santos, D.Sc Universidade Federal de Pernambuco
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lui-s Henrique Sarmento Tenorio, Master's Degree Student, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01449643     History of Changes
Other Study ID Numbers: CAAE-0280.0.172.000-10
First Submitted: October 6, 2011
First Posted: October 10, 2011
Last Update Posted: October 31, 2011
Last Verified: October 2011

Keywords provided by Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco:
Obesity
Diaphragm
Inspiratory muscular training

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes


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