Inspiratory Muscle Training After Gastroplasty

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01084447
First received: March 4, 2010
Last updated: March 9, 2010
Last verified: March 2010

March 4, 2010
March 9, 2010
January 2004
August 2004   (final data collection date for primary outcome measure)
  • Maximum static respiratory pressures [ Time Frame: post-operative days 2, 7, 14, and 30 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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).
Same as current
Complete list of historical versions of study NCT01084447 on ClinicalTrials.gov Archive Site
  • Maximum static respiratory pressures [ Time Frame: post-operative days 2, 7, 14, and 30 ] [ Designated as safety issue: No ]
  • Inspiratory muscular endurance test [ Time Frame: post-operative days 2, 7, 14, and 30 ] [ Designated as safety issue: No ]
  • Spirometric measurements [ Time Frame: post-operative days 2, 7, 14, and 30. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Inspiratory Muscle Training After Gastroplasty
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • 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 Name: respiratory training
  • 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.
  • 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.
    Intervention: Device: control group
  • 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.
    Intervention: Device: inspiratory muscle training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2005
August 2004   (final data collection date for primary outcome measure)

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.
Both
20 Years to 58 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01084447
USP-2010
Yes
Effect of inspiratory muscle training on muscular and pulmonary function following gastroplasty in obese patients, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Ada C Gastaldi, PHD Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
University of Sao Paulo
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP