The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2010
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedOctober 31, 2011
October 1, 2011
11 months
October 6, 2011
October 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ultrasound evaluation of the diaphragm mobility
Compare and correlate diapgragm excursion with pulmonary function.
3 months
Secondary Outcomes (1)
Pulmonary function test
3 months
Study Arms (2)
IMT Group
ACTIVE COMPARATORThreshold 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.
Sham Group
SHAM COMPARATORNon-training protocol
Interventions
Eligibility Criteria
You may qualify if:
- BMI \> 40 kg/m²
- Absence of acute or chronic lung disease
You may not qualify if:
- Acute or chronic inflammatory process
- Thyroid disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Related Publications (1)
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.
PMID: 23651130DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria S Brasileiro-Santos, D.Sc
Universidade Federal de Pernambuco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Degree Student
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 10, 2011
Study Start
September 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 31, 2011
Record last verified: 2011-10