Severe Obesity Clinical Trial
Official title:
Correlation Between Body Composition and the Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery
Verified date | October 2019 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 132 |
Est. completion date | May 8, 2019 |
Est. primary completion date | June 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clinicas da Faculdade de Medicina da USP | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Muscle strength of the lower limbs relative body weight | 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 |
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