Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery

NCT ID: NCT02298517

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Incentive spirometry to flow

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).

Group Type: EXPERIMENTAL

incentive spirometry

Intervention Type: PROCEDURE

Incentive spirometry to flow and incentive spirometry to volume

incentive spirometry to volume

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.

Group Type: EXPERIMENTAL

incentive spirometry

Intervention Type: PROCEDURE

Incentive spirometry to flow and incentive spirometry to volume

inspiratory load equipment-Threshold

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.

Group Type: EXPERIMENTAL

inspiratory load equipment

Intervention Type: PROCEDURE

Threshold and Power breathe

inspiratory load equipment-Power breathe

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.

Group Type: EXPERIMENTAL

inspiratory load equipment

Intervention Type: PROCEDURE

Threshold and Power breathe

Interventions

incentive spirometry

Incentive spirometry to flow and incentive spirometry to volume

Intervention Type: PROCEDURE

inspiratory load equipment

Threshold and Power breathe

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Universidade Metodista de Piracicaba

OTHER

Sponsor Role: lead

Responsible Party

Eli Maria Pazzianotto Forti

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eli M Pazzianotto-Forti, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Metodista de Piracicaba

Locations

Universidade Metodista de Piracicaba (UNIMEP) 13400911

Piracicaba, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31387894 (View on PubMed)

Other Identifiers

UnimepCarol2013

Identifier Type: REGISTRY

Identifier Source: secondary_id

Carol2013

Identifier Type: -

Identifier Source: org_study_id