Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery

Respiratory Tract Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298517
• Other study ID #: Carol2013
• Secondary ID: UnimepCarol2013
• Status: Completed
• Phase: N/A
• First received: December 12, 2013
• Last updated: May 27, 2015
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• incentive spirometry
Incentive spirometry to flow and incentive spirometry to volume
• inspiratory load equipment
Threshold and Power breathe

Locations

Country	Name	City	State
Brazil	Universidade Metodista de Piracicaba (UNIMEP) 13400911	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	THORACOABDOMINAL MOBILITY	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.	Preoperatively and on the high hostitalar - On day 1 and day 3	No
Other	EVALUATION OF MUSCLE STRENGTH INSPIRATORY	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.	Preoperatively and on the high hostitalar - On day 1 and day 3	No
Primary	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.	Preoperatively and on the high hostitalar - On day 1 and day 3	No
Secondary	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.	Preoperatively and on the high hostitalar - On day 1 and day 3	No