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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01449643
First received: October 6, 2011
Last updated: October 28, 2011
Last verified: October 2011

October 6, 2011
October 28, 2011
September 2010
August 2011   (final data collection date for primary outcome measure)
Ultrasound evaluation of the diaphragm mobility [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Compare and correlate diapgragm excursion with pulmonary function.
Ultrasound evaluation of the diaphragm mobility [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01449643 on ClinicalTrials.gov Archive Site
Pulmonary function test [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
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.

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

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Obesity
  • Device: Threshold
  • Device: Sham Threshold
  • 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.
    Intervention: Device: Threshold
  • Sham Comparator: Sham Group
    Non-training protocol
    Intervention: Device: Sham Threshold
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute or chronic inflammatory process
  • Thyroid disorders
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01449643
CAAE-0280.0.172.000-10
No
Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
 
Principal Investigator: Maria S Brasileiro-Santos, D.Sc Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP