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Inspiratory Muscle Training After Gastroplasty

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ClinicalTrials.gov Identifier: NCT01084447
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 4, 2010
First Posted Date  ICMJE March 10, 2010
Last Update Posted Date March 10, 2010
Study Start Date  ICMJE January 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
  • Maximum static respiratory pressures [ Time Frame: post-operative days 2, 7, 14, and 30 ]
  • Inspiratory muscular endurance test [ Time Frame: post-operative days 2, 7, 14, and 30 ]
  • Spirometric measurements [ Time Frame: post-operative days 2, 7, 14, and 30. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inspiratory Muscle Training After Gastroplasty
Official Title  ICMJE Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2010)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01084447
Other Study ID Numbers  ICMJE USP-2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Effect of inspiratory muscle training on muscular and pulmonary function following gastroplasty in obese patients, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ada C Gastaldi, PHD Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date March 2010

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