Inspiratory Muscle Training After Gastroplasty

Phase 1

Completed

• Conditions: Obesity
• Interventions: Device: control group; Device: inspiratory muscle training

• Registration Number: NCT01084447
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-08
• Study Completion: 2005-08
• Status Verified: 2010-03
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-09
• Last Update Submitted: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control group	In placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load.
trained group	inspiratory muscle training	In trained group the respiratory exercise used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)the load was initially set at 40% of the maximal inspiratory pressure.

Primary Outcome Measures

Name	Time	Method
Maximum static respiratory pressures	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	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	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Medicine of Ribeirão Preto, University of Sao Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil