Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02584205
Status:
UNKNOWN
Last Update Posted:
2015-10-22
First Post:
2015-04-08
Brief Title:
Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obstructive sleep apnea OSA is a chronic progressive and disabling disease and can affect functional capacity due to the weakness of the respiratory muscles Therefore the objective of this study is to evaluate the effect of inspiratory muscle training on functional capacity in patients with OSA A pilot study will be conducted to calculate the sample Individuals of both genders diagnosed with obstructive sleep apnea moderate or severe measured by polysomnography will be invited and the data collected in the Sleep Laboratory of the Pronto-Socorro Cardiológico de Pernambuco PROCAPE located in Recife- PE- BRAZIL The study deals with a test-clinical randomized double-blindThe intervention groups held inspiratory muscle training IMT and the load is equivalent to 40 of maximal inspiratory pressure MIP The evaluations will be performed once a week during twelve weeks Control groups will be submitted to a simulated training with load less than 10 of MIP insufficient charge to train the muscles during the same period as the intervention group The guidelines for the training and weekly evaluations will be performed by the responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy Laboratory LACAP- UFPE After the training period the groups will be reassessed by the evaluation tests of functional capacity ADL- Glittre Test and Ergospirometry inspiratory muscle strength manometer and lung function spirometry and then compared Expected results The interventional groups will improve their functional capacity
Detailed Description:
Introduction Obstructive sleep apnea OSA is a chronic progressive and disabling disease and can affect functional capacity due to the weakness of the respiratory muscles The inspiratory muscle training IMT has improved exercise tolerance in other cardiopulmonary diseases such as chronic obstructive pulmonary disease and heart failure Objectives Therefore the objective of this study is to evaluate the effect of inspiratory muscle training on functional capacity in patients with OSA Patients and Methods A pilot study will be conducted to calculate the sample Individuals of both genders diagnosed with obstructive sleep apnea moderate or severe measured by polysomnography will be invited and the data collected in the Sleep Laboratory of the Pronto-Socorro Cardiológico de Pernambuco PROCAPE located in Recife- PE- BRAZIL The study deals with a test-clinical randomized double-blind to be held in four groups A Patients with OSA and Obesity - intervention B Patients with OSA and Obesity - control C Patients with OSA eutrophic - intervention D Patients with OSA eutrophic - control The intervention groups held inspiratory muscle training IMT and the load is equivalent to 40 of maximal inspiratory pressure MIP The evaluations will be performed once a week during twelve weeks Control groups will be submitted to a simulated training with load less than 10 of MIP insufficient charge to train the muscles during the same period as the intervention group The guidelines for the training and weekly evaluations will be performed by the responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy Laboratory LACAP- UFPE After the training period the groups will be reassessed by the evaluation tests of functional capacity ADL-Glittre Test and Ergospirometry inspiratory muscle strength manometer and lung function spirometry and then compared Expected results The interventional groups will improve their functional capacity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None