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Clinical Trials/NCT01084447
NCT01084447
Completed
Phase 1

Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients

University of Sao Paulo1 site in 1 country30 target enrollmentJanuary 2004
ConditionsObesity

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Sao Paulo
Enrollment
30
Locations
1
Primary Endpoint
Maximum static respiratory pressures
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to assess the effect of post-operative inspiratory muscle training on muscle strength and endurance in patients with obesity submitted to gastroplasty.

Detailed Description

Gastroplasties, like other major abdominal surgeries, induce mechanical changes in the lungs and decreases of the respiratory muscle strength in the post-operative periods. Depending on the occurrence of pre-existing disturbs, obese patients may exhibit severe declines of respiratory function after these surgeries. Post-operative respiratory physiotherapy is a valuable intervention, involving a set of techniques aimed to expand pulmonary volumes and to improve arterial oxygenation, leading to decreases on the development of atelectasis and pneumonias. It induces faster recovery of respiratory function and reduction of lung complications, what may be particularly important in high-risk patients like over-weighted subjects. There are scanty data about the role of respiratory muscle training in the post-operative period. This is particularly true regarding inspiratory muscle training of obese patients submitted to gastroplasties.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
August 2005
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • gastroplasty patients presenting body mass index (BMI) ≥ 35 kg/m2;
  • weighting ≤ 60 kg/m2;
  • capable of fulfilling the experimental protocol.

Exclusion Criteria

  • acute or chronic pulmonary disease;
  • post-operative mechanical ventilation for more than 48 hours;
  • presence of lung complications;
  • need for surgical re-intervention during the study period.

Outcomes

Primary Outcomes

Maximum static respiratory pressures

Time Frame: post-operative days 2, 7, 14, and 30

This measurement was made at mouth level by using a properly calibrated manovacuometer (GERAR ®, São Paulo, Brazil), with graduation ranging from 0 to ± 300 cmH2O, connected to a rigid plastic tube.

Inspiratory muscular endurance test

Time Frame: post-operative days 2, 7, 14, and 30.

This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.

Spirometric measurements

Time Frame: post-operative days 2, 7, 14, and 30.

Spirometry was performed according to norms of the American Thoracic Society (ATS) (1994)19 by using a previously calibrated spirometer (Respiradyne II Plus®, Sherwood Medical, St. Louis, USA).

Secondary Outcomes

  • Maximum static respiratory pressures(post-operative days 2, 7, 14, and 30)
  • Inspiratory muscular endurance test(post-operative days 2, 7, 14, and 30)
  • Spirometric measurements(post-operative days 2, 7, 14, and 30.)

Study Sites (1)

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