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
  Purpose

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.


Condition Intervention Phase
Obesity
Device: inspiratory muscle training
Device: control group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: January 2004
Study Completion Date: August 2005
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: respiratory training

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.

  Eligibility

Ages Eligible for Study:   20 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01084447

Locations
Brazil
Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Ada C Gastaldi, PHD Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Effect of inspiratory muscle training on muscular and pulmonary function following gastroplasty in obese patients, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01084447     History of Changes
Other Study ID Numbers: USP-2010
Study First Received: March 4, 2010
Last Updated: March 9, 2010
Health Authority: Brasil: Agência Nacional de Vigilância Sanitária (ANVISA)

Keywords provided by University of Sao Paulo:
obesity
gastroplasty
respiratory muscle training
muscle strength
physical therapy

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014