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Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery

Primary Purpose

Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
incentive spirometry
inspiratory load equipment
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atelectasis focused on measuring Morbid obesity, bariatric surgery, Respiratory muscle endurance, Respiratory muscle strength, spirometry, physiotherapy

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI between 40 and 55 Kg/m²
  • Aged between 25 and 55 years
  • Submitted to Roux-en-Y type gastric by-pass by laparotomy
  • Normal preoperative pulmonary function test

Exclusion Criteria:

  • Hemodynamic instability
  • Hospital stay longer than three days
  • Presence of postoperative complications
  • Smoking

Sites / Locations

  • Universidade Metodista de Piracicaba (UNIMEP) 13400911

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Incentive spirometry to flow

incentive spirometry to volume

inspiratory load equipment-Threshold

inspiratory load equipment-Power breathe

Arm Description

Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.

Was determined for this study that the flow of inspired air will be sufficient to raise up to three spheres. In addition to direct them to do explosive, fast and deep, lifting the ball explosively breaths. Every fifteen inspirations volunteers will be invited to rest for intervals of 30-60 seconds and repeat six times. The use of incentive spirometry was adapted from the recommendations of the American Association for Respiratory Care (1991).

Use of this incentive spirometry will be done as follows: the participants will be instructed to inhale deeply through the mouthpiece, to total lung capacity, starting from functional residual capacity. Will be performed 6 sets of 15 breaths each (deep, slow and sustained) intervals with 30-60 seconds between each series.

This group will use the device Threshold™. Where adjustment is considered 40% of PNSN achieved by the patient evaluation. The volunteer will be instructed to remain in a supine position with 45 ° fowler comfortably with arms and shoulders relaxed and perform an inspiration with enough force to overcome the linear load of the device, then make a normal expiration. This study was determined to carry six sets of 15 repetitions. The rest will be about one to two minutes in each intervention.

To exercise inspiratory muscle in this group will be used device Power breathe ® K2 have the same resistance setting, allowing us to tailor your level of inspiratory muscles. Such adjustment will be made considering 40% of PNSN achieved by the patient in the assessment sniff. For its implementation, the patient will be lying with a tilt of the head of the litter at 45 °, the patient will be asked to inspire to overcome the resistance of the linear unit and after performing a normal expiration. This group will also be achieved 6 series with 15 repetitions each, with an interval of one to two minutes between sets.

Outcomes

Primary Outcome Measures

EVALUATION OF INSPIRATORY MUSCLE ENDURANCE
The endurance test is performed using the Power breathe ® K3. According to Basso and Costa (2012), this assessment divided into two tests: Test incremental: starting with 10 centimeters of water, the volunteer is instructed to breathe normally for two minutes, thereafter a further minute, the next two minutes of exercise load will be increased, and so on until the volunteer fails to reach the predetermined pressure for three consecutive breaths or present dyspnea and / or fatigue. The largest load that is sustained for at least one minute will be considered the value of sustained maximal inspiratory pressure (PImáxS). Test constant: is conducted PImáxS to 80%, which is obtained in the previous test, and determined the time limit (Tlim) run 30 minutes. The stopping criteria are the same as the incremental test.

Secondary Outcome Measures

EVALUATION OF LUNG VOLUMES AND CAPACITIES
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.

Full Information

First Posted
December 12, 2013
Last Updated
May 27, 2015
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02298517
Brief Title
Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery
Official Title
Application of Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery: a Randomized Clinical Trial Blind
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effects of the use of breathing exercises with inspiratory loading on respiratory muscle strength and endurance, lung volumes and capacities and thoracoabdominal mobility in patients after bariatric surgery. It is believed that the use of inspiratory load may mitigate the negative effects of surgical trauma on respiratory muscle dysfunction, preserving respiratory muscle strength, lung volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in the postoperative period.
Detailed Description
This is a prospective, randomized and blinded study, where volunteers will be selected anthropometric measurements, assessment of lung volumes and capacities, through spirometry, thoracoabdominal mobility through the circumference, assessment of inspiratory muscle strength and endurance. After these evaluations will be done by lottery randomization, where the volunteers will be divided into five groups. They are: control, incentive spirometry to flow, the volume incentive spirometry, Threshold ™, Power breathe ®, according to their resources to be performed during the postoperative period. Each appeal will be held in 6 sets of 15 repetitions, totaling seven sessions, two in the immediate postoperative period, and five on the first postoperative day. At the end of the intervention volunteers will be reassessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
Keywords
Morbid obesity, bariatric surgery, Respiratory muscle endurance, Respiratory muscle strength, spirometry, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.
Arm Title
Incentive spirometry to flow
Arm Type
Experimental
Arm Description
Was determined for this study that the flow of inspired air will be sufficient to raise up to three spheres. In addition to direct them to do explosive, fast and deep, lifting the ball explosively breaths. Every fifteen inspirations volunteers will be invited to rest for intervals of 30-60 seconds and repeat six times. The use of incentive spirometry was adapted from the recommendations of the American Association for Respiratory Care (1991).
Arm Title
incentive spirometry to volume
Arm Type
Experimental
Arm Description
Use of this incentive spirometry will be done as follows: the participants will be instructed to inhale deeply through the mouthpiece, to total lung capacity, starting from functional residual capacity. Will be performed 6 sets of 15 breaths each (deep, slow and sustained) intervals with 30-60 seconds between each series.
Arm Title
inspiratory load equipment-Threshold
Arm Type
Experimental
Arm Description
This group will use the device Threshold™. Where adjustment is considered 40% of PNSN achieved by the patient evaluation. The volunteer will be instructed to remain in a supine position with 45 ° fowler comfortably with arms and shoulders relaxed and perform an inspiration with enough force to overcome the linear load of the device, then make a normal expiration. This study was determined to carry six sets of 15 repetitions. The rest will be about one to two minutes in each intervention.
Arm Title
inspiratory load equipment-Power breathe
Arm Type
Experimental
Arm Description
To exercise inspiratory muscle in this group will be used device Power breathe ® K2 have the same resistance setting, allowing us to tailor your level of inspiratory muscles. Such adjustment will be made considering 40% of PNSN achieved by the patient in the assessment sniff. For its implementation, the patient will be lying with a tilt of the head of the litter at 45 °, the patient will be asked to inspire to overcome the resistance of the linear unit and after performing a normal expiration. This group will also be achieved 6 series with 15 repetitions each, with an interval of one to two minutes between sets.
Intervention Type
Procedure
Intervention Name(s)
incentive spirometry
Intervention Description
Incentive spirometry to flow and incentive spirometry to volume
Intervention Type
Procedure
Intervention Name(s)
inspiratory load equipment
Intervention Description
Threshold and Power breathe
Primary Outcome Measure Information:
Title
EVALUATION OF INSPIRATORY MUSCLE ENDURANCE
Description
The endurance test is performed using the Power breathe ® K3. According to Basso and Costa (2012), this assessment divided into two tests: Test incremental: starting with 10 centimeters of water, the volunteer is instructed to breathe normally for two minutes, thereafter a further minute, the next two minutes of exercise load will be increased, and so on until the volunteer fails to reach the predetermined pressure for three consecutive breaths or present dyspnea and / or fatigue. The largest load that is sustained for at least one minute will be considered the value of sustained maximal inspiratory pressure (PImáxS). Test constant: is conducted PImáxS to 80%, which is obtained in the previous test, and determined the time limit (Tlim) run 30 minutes. The stopping criteria are the same as the incremental test.
Time Frame
Preoperatively and on the high hostitalar - On day 1 and day 3
Secondary Outcome Measure Information:
Title
EVALUATION OF LUNG VOLUMES AND CAPACITIES
Description
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.
Time Frame
Preoperatively and on the high hostitalar - On day 1 and day 3
Other Pre-specified Outcome Measures:
Title
THORACOABDOMINAL MOBILITY
Description
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Time Frame
Preoperatively and on the high hostitalar - On day 1 and day 3
Title
EVALUATION OF MUSCLE STRENGTH INSPIRATORY
Description
The Sniff is an alternative non-invasive technique for the assessment of inspiratory muscle strength by sniff nasal inspiratory pressure (PNSN). The measurement is performed using a peak pressure generated by nasal nostril during a maximal sniff from functional residual capacity (FRC). The measurement will be performed with one nostril occluded by a silicone nasal plug, which remained connected to the digital manometer by a catheter approximately 1mm diameter (RUPPEL, 1994). The maneuver is a maximal sniff, with the mouth closed, from functional residual capacity (FRC). The Sniff Test will be held in ten maneuvers, with an interval of 30 seconds between each maneuver, being used as a selection criterion Sniff acceptable to generate a peak pressure regularly and a duration between 0 and 5 sec.
Time Frame
Preoperatively and on the high hostitalar - On day 1 and day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 40 and 55 Kg/m² Aged between 25 and 55 years Submitted to Roux-en-Y type gastric by-pass by laparotomy Normal preoperative pulmonary function test Exclusion Criteria: Hemodynamic instability Hospital stay longer than three days Presence of postoperative complications Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli M Pazzianotto-Forti, PhD
Organizational Affiliation
Universidade Metodista de Piracicaba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Metodista de Piracicaba (UNIMEP) 13400911
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13400911
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31387894
Citation
Pazzianotto-Forti EM, da Costa Munno CM, Merino DFB, Simoes da Rocha MR, de Mori TA, Junior IR. Effects of Inspiratory Exercise With Linear and Nonlinear Load on Respiratory Variables Post-Bariatric Surgery. Respir Care. 2019 Dec;64(12):1516-1522. doi: 10.4187/respcare.05841. Epub 2019 Aug 6.
Results Reference
derived

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Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery

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