Inspiratory Muscle Training After Gastroplasty

March 9, 2010 updated by: University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Faculty of Medicine of Ribeirão Preto, University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 58 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 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.
Device: control group
In placebo muscular training the daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)no load until the 30th post-operative day.
ACTIVE_COMPARATOR: trained group
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.
Device: inspiratory muscle training
This daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)was initially set at 40% of the maximal inspiratory pressure, obtained in the 2nd post-operative day, being adjusted to every new maximal inspiratory pressure measurement.
Other Names:
  • respiratory training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post-operative days 2, 7, 14, and 30
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.
post-operative days 2, 7, 14, and 30.
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).
post-operative days 2, 7, 14, and 30.

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum static respiratory pressures
Time Frame: post-operative days 2, 7, 14, and 30
post-operative days 2, 7, 14, and 30
Inspiratory muscular endurance test
Time Frame: post-operative days 2, 7, 14, and 30
post-operative days 2, 7, 14, and 30
Spirometric measurements
Time Frame: post-operative days 2, 7, 14, and 30.
post-operative days 2, 7, 14, and 30.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Ada C Gastaldi, PHD, Faculty of Medicine of Ribeirao Preto-University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

August 1, 2004

Study Completion (ACTUAL)

August 1, 2005

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (ESTIMATE)

March 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2010

Last Update Submitted That Met QC Criteria

March 9, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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