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Clinical Trials/NCT02298517
NCT02298517CompletedNot Applicable

Application of Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery: a Randomized Clinical Trial Blind

Universidade Metodista de Piracicaba1 site in 1 country114 target enrollmentStarted: December 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
114
Locations
1
Primary Endpoint
EVALUATION OF INSPIRATORY MUSCLE ENDURANCE

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control

No Intervention

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

Incentive spirometry to flow

Experimental

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).

Intervention: incentive spirometry (Procedure)

incentive spirometry to volume

Experimental

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.

Intervention: incentive spirometry (Procedure)

inspiratory load equipment-Threshold

Experimental

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.

Intervention: inspiratory load equipment (Procedure)

inspiratory load equipment-Power breathe

Experimental

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: inspiratory load equipment (Procedure)

Outcomes

Primary Outcomes

EVALUATION OF INSPIRATORY MUSCLE ENDURANCE

Time Frame: Preoperatively and on the high hostitalar - On day 1 and day 3

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 Outcomes

  • EVALUATION OF LUNG VOLUMES AND CAPACITIES(Preoperatively and on the high hostitalar - On day 1 and day 3)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eli Maria Pazzianotto Forti

PhD

Universidade Metodista de Piracicaba

Study Sites (1)

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