Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery

October 14, 2019 updated by: Roberto de Cleva, University of Sao Paulo General Hospital

Correlation Between Body Composition and the Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery

Excessive fat mass (FM) contributes to changes in the strength and endurance of skeletal muscles. Mid-thigh muscle mass is approximately 2.5 times that of fat mass, but individuals who are obese have increased intra- (fat within muscle cells) and intermuscular fat (fat between muscle cells), establishing a negative influence on strength generation capacity and functional independence. The functional capacity of a skeletal muscle can be assessed based on the muscle's ability to produce strength. The relevance of this study is to identify/analyze the changes in segmental body composition (BC) which might better determine the association between fat free mass (FFM) of the lower limbs and maximum voluntary contraction (MVC), 36 months after bariatric surgery. This study was elaborated and will be performed at the Clinical Hospital in the Medical School of the University of Sao Paulo (HCFMUSP). The patients involved will receive the Informed Consent Form. The sample, consists of 155 adults selected at the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP in the periods: preoperative, 6 and 36 months after surgery. Patients of both sexes, above 18 years of age, will undergo bariatric surgery performed at the institution. Adult patients over 60 years old, undergoing revision surgery and other surgical techniques will be excluded. Anthropometric variables will be obtained on the same day as the evaluation of BC by trained evaluators. The BC will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Evaluation of Body Composition and Muscle Strength will be held between 8:00 am and 10:00 am in the Laboratory of Exercise and Movement Studies at the Institute of Orthopedics and Traumatology of FMUSP. BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance. The dynamometer will be used to evaluate muscle strength extension (Ext) and flexion (Flex) MVC torques for both legs will be carried. The MVC assessed variables should be absolute Ext and Flex torques (Nm), Ext and Flex torques relative to the body weight (Nm/Bw) and Ext and Flex torques relative to FFM (Nm/FFM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anthropometric Assessment Anthropometric variables will be obtained on the same day as the evaluation of BC by trained evaluators. The body weight (kg) will be measured by In Body 230, 2.0, (Biospace Seoul, Korea). The patient should be in the orthostatic position, facing the display, in the center of the scale, barefoot, in light clothes. The height measurement (m) will be performed in a stadiometer coupled to the scale W 300, Class III, with a maximum capacity of 2m. The patient will be kept with his back to the meter, with the feet united, in an erect position, looking at horizon and arms extended to the side of the body. The reading will be made in the nearest centimeter when the horizontal rod of the vertical bar of the stature scale rests against the individual's head. BMI (kg/m2) will be determined by dividing body weight (kg) by height (m) squared.

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.

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403900
        • Hospital das Clinicas da Faculdade de Medicina da USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe obesity undergoing bariatric surgery in the Bariatric Metabolic Surgical Unit of the Hospital das Clínicas, University of São Paulo Medical School.

Description

Inclusion Criteria:

  • Body mass index (BMI) between 40 and 60 kg/m2.

Exclusion Criteria:

  • Functional disability
  • Treatment with steroid medication for any reason.
  • Use of artificial devices such as an orthosis or a prosthesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Muscle strength of the lower limbs
Time Frame: 6 months after bariatric surgery
Will be evaluated by Biodex Multi-joint System 3 dynamometer that measured the muscle strength of lower limbs by Extension (Ext) and flexion (Flex) torques absolute maximum voluntary contraction (MVC) Newton meter (Nm)
6 months after bariatric surgery
Changes in Muscle strength of the lower limbs
Time Frame: 36 months after bariatric surgery
Will be evaluated by Biodex Multi-joint System 3 dynamometer that measured the muscle strength of lower limbs by Extension (Ext) and flexion (Flex) torques MVC, Nm
36 months after bariatric surgery
Changes in Body composition
Time Frame: 6 months after bariatric surgery
Will be evaluated by electrical bioimpedance (InBody 230) that gives automatically data of: Fat Free Mass (FFM) (kg, %), Fat Mass (FM)(kg,%), Fat Free Mass of lower limbs (FFMLL) (kg, %), Fat Mass of lower limbs (FMLL) (kg,%). kilograms (Kg) e percentual (%).
6 months after bariatric surgery
Changes in Body composition
Time Frame: 36 months after bariatric surgery
Will be evaluated by electrical bioimpedance (InBody 230) that gives automatically data of: FFM (kg, %), FM (kg,%), FFMLL (kg, %), FMLL (kg,%).
36 months after bariatric surgery
Changes in Muscle strength of the lower limbs relative by fat free mass of lower limbs
Time Frame: 6 months after bariatric surgery
The results of muscle strength of lower limbs by Ext and Flex torques MVC Nm corrected by FFM (kg, %) obtained by assesment bioimpedance
6 months after bariatric surgery
Changes in Muscle strength of the lower limbs relative by fat free mass of lower limbs
Time Frame: 36 months after bariatric surgery
The results of muscle strength of lower limbs by Ext and Flex torques MVC Nm corrected by FFM (kg, %) obtained by assesment bioimpedance
36 months after bariatric surgery
Correlate muscle strength of the lower limbs with reduction of fat free mass
Time Frame: 6 and 36 months after bariatric surgery
Will be correlated the data of measured the muscle strength of lower limbs Nm with FFM (kg, %)
6 and 36 months after bariatric surgery
Correlate muscle strength of the lower limbs with reduction of fat mass
Time Frame: 6 and 36 months after bariatric surgery
Will be correlated the data of measured the muscle strength of lower limbs Nm with FM (Kg, %)
6 and 36 months after bariatric surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength of the lower limbs relative body weight
Time Frame: 6 months and 36 months after bariatric surgery
This data is obtained automatically by dynamometer that correct the muscle strength of lower limbs by body weight
6 months and 36 months after bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Chair: Roberto de Cleva, MD Phd, Clinical Hospital of University of Sao Paulo Medical School
  • Principal Investigator: Alexandre Gadducci, MsC, University of Sao Paulo Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

May 8, 2019

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01038912.6.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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