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

NCT04129801 | Completed

• 1 other identifier: 01038912.6.0000.0068
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Severe Obesity

Keywords

Severe obesity; Body Composition; Muscle Strength; Electrical bioimpedance analysis

Outcome Measures

Primary Outcomes (8)

• Changes in Muscle strength of the lower limbs

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Muscle strength of the lower limbs relative body weight

  6 months and 36 months after bariatric surgery

Study Arms (1)

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; Other: Bioimpedance

Interventions

Isokinetic Dynamometer OTHER

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.

Prospective analysis

Bioimpedance OTHER

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).

Prospective analysis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403900, Brazil

Location

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MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto de Cleva, MD Phd

  Clinical Hospital of University of Sao Paulo Medical School

  STUDY CHAIR

• Alexandre Gadducci, MsC

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigador

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: October 17, 2019
• Study Start: May 5, 2017
• Primary Completion: June 15, 2017
• Study Completion: May 8, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

BR (1)