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

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. Identifier: NCT01449643
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : October 31, 2011
Information provided by (Responsible Party):
Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Device: Threshold Device: Sham Threshold Not Applicable

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  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute or chronic inflammatory process
  • Thyroid disorders

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 identifier (NCT number): NCT01449643

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

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

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

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