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临床试验/NCT02298517
NCT02298517已完成不适用

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

Universidade Metodista de Piracicaba1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
EVALUATION OF INSPIRATORY MUSCLE ENDURANCE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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).

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: inspiratory load equipment (Procedure)

结局指标

主要结局

EVALUATION OF INSPIRATORY MUSCLE ENDURANCE

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eli Maria Pazzianotto Forti

PhD

Universidade Metodista de Piracicaba

研究点 (1)

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