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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01321983
Other study ID # 141299/2009-6
Secondary ID
Status Completed
Phase N/A
First received March 23, 2011
Last updated March 23, 2011

Study information

Verified date March 2011
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority Brazil: Federal University of São Carlos - UFSCarBrazil: National Council for Scientific and Technological Development - CNPqBrazil: Meridional Hospital
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Other:
Inspiratory muscular training - IMT


Locations

Country Name City State
Brazil Meridional Hospital Cariacica Espirito Santo

Sponsors (3)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos Conselho Nacional de Desenvolvimento Científico e Tecnológico, Meridional Hospital

Country where clinical trial is conducted

Brazil, 

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