Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery
Application of Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery: a Randomized Clinical Trial Blind
2 other identifiers
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 28, 2015
May 1, 2015
10 months
December 12, 2013
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
EVALUATION OF LUNG VOLUMES AND CAPACITIES
Preoperatively and on the high hostitalar - On day 1 and day 3
Other Outcomes (2)
THORACOABDOMINAL MOBILITY
Preoperatively and on the high hostitalar - On day 1 and day 3
EVALUATION OF MUSCLE STRENGTH INSPIRATORY
Preoperatively and on the high hostitalar - On day 1 and day 3
Study Arms (5)
Control
NO INTERVENTIONIndividuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.
Incentive spirometry to flow
EXPERIMENTALWas 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).
incentive spirometry to volume
EXPERIMENTALUse 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.
inspiratory load equipment-Threshold
EXPERIMENTALThis 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.
inspiratory load equipment-Power breathe
EXPERIMENTALTo 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.
Interventions
Incentive spirometry to flow and incentive spirometry to volume
Threshold and Power breathe
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hemodynamic instability
- Hospital stay longer than three days
- Presence of postoperative complications
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Metodista de Piracicaba (UNIMEP) 13400911
Piracicaba, São Paulo, 13400911, Brazil
Related Publications (1)
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.
PMID: 31387894DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eli M Pazzianotto-Forti, PhD
Universidade Metodista de Piracicaba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 12, 2013
First Posted
November 24, 2014
Study Start
December 1, 2013
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
May 28, 2015
Record last verified: 2015-05