Clinical trial NCT01872663: Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery
Official title: Influence of Different Physical Therapy Resources Application After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Respiratory Tract Diseases
Pathological Conditions, Signs and Symptoms
Keywords: Morbid obesity
Bariatric surgery
Pulmonary atelectasis
Spirometry
Continuos Positive Airway Pressure
Physical therapy speciality
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2013-06-07
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty.

It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung function and prevention of pulmonary complications and can thus identify the resources that can contribute more effectively in post-operative bariatric surgery.

Detailed description: The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing Roux-en-Y gastric by-pass with regard to: lung volumes and capacities, prevalence of atelectasis, thoracoabdominal mobility and evaluation of peak flow of cough, evaluated pre and post operative.

Individuals with BMI between 40 and 55 Kg/m², aged between 25 and 55 years, underwent the surgical procedure Roux-en-Y type gastric by-pass by laparotomy and normal preoperative pulmonary function will be included.

The volunteers will be divided into seven different groups, according to the treatment received during hospitalization after surgery:

G control: subjects treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital; G Voldyne: subjects treated with incentive spirometry, Voldyne Model 5000® (Sherwood Medical, USA); G CPAP: subjects treated with "continuous positive airway pressure"; G EPAP: subjects treated with "expiratory positive airway pressure"; G IPPB: subjects treated with "intermittent positive pressure breathing"; G BIPAP: subjects treated with "bi-level positive airway pressure"; G BS: subjects treated with "breath stacking" (siliconized mask connected to a unidirectional valve allowing only inspiration).

The application of resources will be held twice a day in the immediate and in the first postoperative sessions in 6 sets of 15 reps or 30 continuous minutes, with an interval of 4 hours between sessions. The researcher will remain alongside the volunteers, following them and monitoring vital signs and respiratory comfort.

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

Primary outcomes:
measure: Pulmonary function
timeFrame: 2 days after surgery
Secondary outcomes:
measure: Prevalence of atelectasis
timeFrame: 2 days after surgery
measure: Thoracoabdominal mobility
timeFrame: 2 days after surgery
measure: Peak cough flow
timeFrame: 2 days after surgery
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Universidade Metodista de Piracicaba (UNIMEP)
state: São Paulo
Study officials:
References:
citation: Brigatto P, Carbinatto JC, Costa CM, Montebelo MI, Rasera-Junior I, Pazzianotto-Forti EM. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial. Braz J Phys Ther. 2014 Nov-Dec;18(6):553-62. doi: 10.1590/bjpt-rbf.2014.0054. Epub 2015 Jan 9.