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Inspiratory Muscle Training After Gastroplasty

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
inspiratory muscle training
control group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, gastroplasty, respiratory muscle training, muscle strength, physical therapy

Eligibility Criteria

20 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine of Ribeirão Preto, University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

trained group

Arm Description

In placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load.

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.

Outcomes

Primary Outcome Measures

Maximum static respiratory pressures
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
This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.
Spirometric measurements
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
Inspiratory muscular endurance test
Spirometric measurements

Full Information

First Posted
March 4, 2010
Last Updated
March 9, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01084447
Brief Title
Inspiratory Muscle Training After Gastroplasty
Official Title
Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, gastroplasty, respiratory muscle training, muscle strength, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
In placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load.
Arm Title
trained group
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
inspiratory muscle training
Other Intervention Name(s)
respiratory training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
control group
Intervention Description
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 Outcome Measure Information:
Title
Maximum static respiratory pressures
Description
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.
Time Frame
post-operative days 2, 7, 14, and 30
Title
Inspiratory muscular endurance test
Description
This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.
Time Frame
post-operative days 2, 7, 14, and 30.
Title
Spirometric measurements
Description
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).
Time Frame
post-operative days 2, 7, 14, and 30.
Secondary Outcome Measure Information:
Title
Maximum static respiratory pressures
Time Frame
post-operative days 2, 7, 14, and 30
Title
Inspiratory muscular endurance test
Time Frame
post-operative days 2, 7, 14, and 30
Title
Spirometric measurements
Time Frame
post-operative days 2, 7, 14, and 30.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada C Gastaldi, PHD
Organizational Affiliation
Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
2024569
Citation
Christensen EF, Schultz P, Jensen OV, Egebo K, Engberg M, Gron I, Juhl B. Postoperative pulmonary complications and lung function in high-risk patients: a comparison of three physiotherapy regimens after upper abdominal surgery in general anesthesia. Acta Anaesthesiol Scand. 1991 Feb;35(2):97-104. doi: 10.1111/j.1399-6576.1991.tb03255.x.
Results Reference
background
PubMed Identifier
18057088
Citation
Dronkers J, Veldman A, Hoberg E, van der Waal C, van Meeteren N. Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study. Clin Rehabil. 2008 Feb;22(2):134-42. doi: 10.1177/0269215507081574. Epub 2007 Dec 5.
Results Reference
background
PubMed Identifier
21229331
Citation
Casali CC, Pereira AP, Martinez JA, de Souza HC, Gastaldi AC. Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. Obes Surg. 2011 Sep;21(9):1389-94. doi: 10.1007/s11695-010-0349-y.
Results Reference
derived

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Inspiratory Muscle Training After Gastroplasty

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