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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Pernambuco:

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


Secondary Outcome Measures:
  • Pulmonary function test [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Universidade Federal de Pernambuco

Additional 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
Study First Received: October 6, 2011
Last Updated: October 28, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Pernambuco:
Obesity
Diaphragm
Inspiratory muscular training

Additional relevant MeSH terms:
Respiratory Aspiration
Obesity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight

ClinicalTrials.gov processed this record on July 20, 2014