Back to resultsThe Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Threshold
Sham Threshold
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity focused on measuring Obesity, Diaphragm, Inspiratory muscular training
Eligibility Criteria
Inclusion Criteria:
- BMI > 40 kg/m²
- Absence of acute or chronic lung disease
Exclusion Criteria:
- Acute or chronic inflammatory process
- Thyroid disorders
Sites / Locations
- Universidade Federal de Pernambuco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
IMT Group
Sham Group
Arm Description
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.
Non-training protocol
Outcomes
Primary Outcome Measures
Ultrasound evaluation of the diaphragm mobility
Compare and correlate diapgragm excursion with pulmonary function.
Secondary Outcome Measures
Pulmonary function test
Full Information
NCT ID
NCT01449643
First Posted
October 6, 2011
Last Updated
October 28, 2011
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT01449643
Brief Title
The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
Official Title
The Influence of Inspiratory Muscular Training on Diaphragmatic Mobility, Lung Function and Quality of Life in Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Diaphragm, Inspiratory muscular training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Non-training protocol
Intervention Type
Device
Intervention Name(s)
Threshold
Intervention Type
Device
Intervention Name(s)
Sham Threshold
Primary Outcome Measure Information:
Title
Ultrasound evaluation of the diaphragm mobility
Description
Compare and correlate diapgragm excursion with pulmonary function.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pulmonary function test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI > 40 kg/m²
Absence of acute or chronic lung disease
Exclusion Criteria:
Acute or chronic inflammatory process
Thyroid disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria S Brasileiro-Santos, D.Sc
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23651130
Citation
Tenorio LH, Santos AC, Camara Neto JB, Amaral FJ, Passos VM, Lima AM, Brasileiro-Santos Mdo S. The influence of inspiratory muscle training on diaphragmatic mobility, pulmonary function and maximum respiratory pressures in morbidly obese individuals: a pilot study. Disabil Rehabil. 2013;35(22):1915-20. doi: 10.3109/09638288.2013.769635. Epub 2013 May 7.
Results Reference
derived
Learn more about this trial
The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
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