Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery
Primary Purpose
Preoperative Inspiratory Muscular Training, Bariatric Surgery, Chest Physiotherapy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscular training - IMT
Sponsored by
About this trial
This is an interventional trial for Preoperative Inspiratory Muscular Training
Eligibility Criteria
Inclusion Criteria:
- Female,
- Over 18 years of age,
- No smoking or respiratory disease.
Exclusion Criteria:
- Patients who refused to participate in the steps of the research protocol,
- Patients with a history of prior abdominal surgery,
- Patients who were unable to understand and perform the tests properly
- Patients who refused to sign the Informed Consent Term.
Sites / Locations
- Meridional Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01321983
First Posted
March 23, 2011
Last Updated
March 23, 2011
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Meridional Hospital, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01321983
Brief Title
Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery
Official Title
Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery: Respiratory Muscle Strength, Lung Volumes and Diaphragmatic Excursion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Meridional Hospital, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.
Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients undergoing open bariatric surgery.
DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil. SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly assigned to receive preoperative inspiratory muscle training (IMT group) or usual care (control group).
MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP), lung volumes and diaphragmatic excursion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Inspiratory Muscular Training, Bariatric Surgery, Chest Physiotherapy, Postoperative Pulmonary Complications, Obesity
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Inspiratory muscular training - IMT
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
Female,
Over 18 years of age,
No smoking or respiratory disease.
Exclusion Criteria:
Patients who refused to participate in the steps of the research protocol,
Patients with a history of prior abdominal surgery,
Patients who were unable to understand and perform the tests properly
Patients who refused to sign the Informed Consent Term.
Facility Information:
Facility Name
Meridional Hospital
City
Cariacica
State/Province
Espirito Santo
ZIP/Postal Code
29151920
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://www.ufscar.br
Description
Related Info
Learn more about this trial
Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery
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