Ignite Creation Date:
2024-05-06 @ 7:07 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02478619
Status:
UNKNOWN
Last Update Posted:
2016-05-19
First Post:
2015-06-16
Brief Title:
Preoperative Inspiratory Muscle Training in Gastroplasty
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Effects of Preoperative Inspiratory Muscle Training in Patients Undergoing Gastroplasty
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
ACTIVE_NOT_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:
The purpose of this study is to assess the effect of preoperative inspiratory muscle training in patients with grade III obesity undergoing bariatric surgery It will be a double-blind randomized controlled clinical trial with volunteers allocated in two groups that will be compared according to postoperative evolution pulmonary complications lung function strength and endurance of the respiratory muscles and respiratory system resistance
Detailed Description:
The prevalence of obesity has a significantly increase in recent years and represents a public health problem due to the increased risk of mortality from various causes Changes in respiratory system arising from obesity are well established and they include a reduction in compliance with an increased ventilatory work and oxygen consumption with breathing Bariatric surgery is an alternative surgical treatment of obesity and patients who undergo this surgery are susceptible to post operative pulmonary complications as a result of obesity and also abdominal surgery The inspiratory muscle training IMT used in pre or post operative period can improve muscle strength and endurance beyond the perception of dyspneaThere are suggestions that the preoperative training may contribute to a best post operative evolution in patients but these benefits are not clearly defined in the literature The objective is to evaluate the effects of preoperative IMT in post operative patients undergoing gastroplasty There will be 40 patients of bariatric surgery group in Ribeirão Preto Medical School of both sexes BMI40 kgm2 and with the appropriate inclusion criteriaThey will be assessed by pulmonary function tests measurement of strength and endurance of respiratory muscles submaximal exercise tests dyspnea and quality of life scales All patients will receive standard treatment and will be randomly divided into two groups named control group and training group who will be trained for 4 weeks preoperatively The patients will be reassessed after 4 weeks of training and on the 15th postoperative return day The evolution data about pulmonary complications will be collected from the medical records notes of the medical staff and physical therapy routine service
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