Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery
NCT ID: NCT04129801
Last Updated: 2019-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
132 participants
OBSERVATIONAL
2017-05-05
2019-05-08
Brief Summary
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Detailed Description
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Bioimpedance Body composition will be determined by bioelectrical impedance analysis (BIA) under constant conditions (with subjects appropriately hydrated and at the same time of day).The body composition analyzer (InBody230, Biospace Co., Gangnam-gu, Seoul, South Korea) was a segmental impedance device that uses a tetrapolar 8-point tactile electrode system, and the measured weight range was 10 to 250 kg. Impedance measurements were performed by utilizing 2 different frequencies (20 and 100 kHz) at each segment (the right arm, left arm, trunk, right leg, and left leg). The participant will be positioned in orthostatic position on a platform with lower electrodes for the feet and two brackets (the upper electrodes) gripped on hands. Data output was calculated in percentages (%) and included FM, FFM, trunk FFM, and appendicular FFM (the sum of the FFM values for the right arm, left arm, right leg, and left leg).
Isokinetic dynamometer The muscular strength evaluation will be performed on the isokinetic dynamometer, Biodex ® Multi-joint System 3 (Biodex Medical Systems Inc, Shirley, New York, USA). The dynamometer is calibrated thirty minutes before the start of the tests.
Participants are positioned for evaluation in the concentric / concentric mode of knee joint extension and flexion movements. Individuals remain seated with their hip at 90º of flexion, affixed to the chair with chest X-belts, a strap around the pelvic girdle, a strap over the distal third of the thigh and one at the distal third of the assessed leg, way to free the movements of the ankle.
All participants are instructed to perform four movements with submaximal force to familiarize themselves with the equipment. The test is performed first on the dominant limb and later on the non-dominant limb. The assessed limb is positioned with the lateral femoral condyle (axis of the knee joint movement) aligned to the mechanical axis of the dynamometer. The member that is not being evaluated will be aligned with the other member. The volunteers are instructed to perform two sets of 4 uninterrupted repetitions of knee extension and flexion with interval of 60 seconds. Throughout the period of the test, standardized and constant verbal encouragement is performed to obtain as much force as possible during contractions.
The tests are performed with concentric movements of flexion and extension of the knee, starting from 90º of flexion and reaching 20º of extension, with correction of the force of gravity.
The angular velocity used will be 60 degrees per second (60º / s).
The variables that will be obtained through the evaluation of muscular strength are:
Torque Peak (Nm): is the maximum force reached in each of the repetitions in which the test was performed. The peak torque represents the largest muscle contraction in the arc of movement and corresponds to the highest point of the force x distance curve.
Peak torque relative to body weight (Nm / kg): maximum force corrected for body weight, the result being expressed in percent newton-kilogram.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective analysis
Bioimpedance The BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance (BIA) 230, 2.0, (Biospace Seoul, Korea). Those evaluated will be standing and positioned on the platform electrodes, barefoot and with their arms extended with their hands on the two supports (electrodes).
Evaluation of Muscle Strength was used The Biodex Multi-joint System 3 dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) to measure isokinetic extension (Ext) and flexion (Flex) MVC torques for both legs.
Isokinetic Dynamometer
Participants then executed two series of four uninterrupted repetitions of Ext and Flex of both legs, first with the dominant member and subsequently with the non-dominant member, at an angular velocity of 60o/s, with a 60-second interval between series.
Bioimpedance
Bioimpedance The BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance (BIA) 230, 2.0, (Biospace Seoul, Korea). Those evaluated will be standing and positioned on the platform electrodes, barefoot and with their arms extended with their hands on the two supports (electrodes).
Interventions
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Isokinetic Dynamometer
Participants then executed two series of four uninterrupted repetitions of Ext and Flex of both legs, first with the dominant member and subsequently with the non-dominant member, at an angular velocity of 60o/s, with a 60-second interval between series.
Bioimpedance
Bioimpedance The BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance (BIA) 230, 2.0, (Biospace Seoul, Korea). Those evaluated will be standing and positioned on the platform electrodes, barefoot and with their arms extended with their hands on the two supports (electrodes).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Treatment with steroid medication for any reason.
* Use of artificial devices such as an orthosis or a prosthesis.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Roberto de Cleva
Principal investigador
Principal Investigators
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Roberto de Cleva, MD Phd
Role: STUDY_CHAIR
Clinical Hospital of University of Sao Paulo Medical School
Alexandre Gadducci, MsC
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo Medical School
Locations
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Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, , Brazil
Countries
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References
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Other Identifiers
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01038912.6.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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