CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
Isokinetic Dynamometer +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04129801
NCT04129801N/ACompleted

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

University of Sao Paulo General Hospital·observational·Posted Oct 17, 2019·Updated Oct 17, 2019

In Brief

An observational study evaluating Isokinetic Dynamometer and Bioimpedance for Severe Obesity. Completed, enrolled 132 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Obesity
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 17, 2019
Enrollment StartMay 5, 2017
Primary CompletionJun 15, 2017
Study CompletionMay 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.7 years ago

Interventions

Isokinetic Dynamometerother

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.

Bioimpedanceother

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).