Skip to main content
OpenTrials
Completed

NCT Number: NCT01084447

Inspiratory Muscle Training After Gastroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Medicine of Ribeirão Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory muscle training

Device

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

Control group

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Maximum static respiratory pressures

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

  2. Inspiratory muscular endurance test

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

  3. Spirometric measurements

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2005
First posted
Mar 10, 2010
Registry last updated
Mar 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.