NCT01321983

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

First QC Date

March 23, 2011

Last Update Submit

March 23, 2011

Conditions

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female,
  • Over 18 years of age,
  • No smoking or respiratory disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meridional Hospital

Cariacica, Espírito Santo, 29151920, Brazil

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations