Severe ObesityNCT04129801
Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery
An observational study of Severe Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Isokinetic Dynamometer and Bioimpedance
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- 5 May 2017to 8 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Body mass index (BMI) between 40 and 60 kg/m2.
Who cannot join
- Functional disability
- Treatment with steroid medication for any reason.
- Use of artificial devices such as an orthosis or a prosthesis.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403900
About this study
Official title: 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).
Read the 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.
- Conditions
- Severe Obesity
- Being tested
- Isokinetic Dynamometer, Bioimpedance
- Keywords
- Severe obesity, Body Composition, Muscle Strength, Electrical bioimpedance analysis
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Isokinetic Dynamometer; Other: Bioimpedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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 (%).
Measured: 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,%).
Measured: 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
Measured: 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
Measured: 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, %)
Measured: 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, %)
Measured: 6 and 36 months after bariatric surgery
Secondary outcomes (1)
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
Measured: 6 months and 36 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start5 May 2017
- Primary completion15 Jun 2017
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto de Cleva, University of Sao Paulo General Hospital
- Investigators
- Roberto de Cleva, MD Phd, Study chair, Clinical Hospital of University of Sao Paulo Medical SchoolAlexandre Gadducci, MsC, Principal investigator, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129801
- Sponsor's protocol ID
- 01038912.6.0000.0068
- Status last verified
- Oct 2019
- First submitted
- 21 May 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira-Lancha LO, Campos-Ferraz PL, Lancha AH Jr. Obesity: considerations about etiology, metabolism, and the use of experimental models. Diabetes Metab Syndr Obes. 2012;5:75-87. doi: 10.2147/DMSO.S25026. Epub 2012 Apr 10.
PubMed 22570558Okoro CA, Hootman JM, Strine TW, Balluz LS, Mokdad AH. Disability, arthritis, and body weight among adults 45 years and older. Obes Res. 2004 May;12(5):854-61. doi: 10.1038/oby.2004.103.
PubMed 15166307Syed IY, Davis BL. Obesity and osteoarthritis of the knee: hypotheses concerning the relationship between ground reaction forces and quadriceps fatigue in long-duration walking. Med Hypotheses. 2000 Feb;54(2):182-5. doi: 10.1054/mehy.1999.0013.
PubMed 10790748Anandacoomarasamy A, Fransen M, March L. Obesity and the musculoskeletal system. Curr Opin Rheumatol. 2009 Jan;21(1):71-7. doi: 10.1097/bor.0b013e32831bc0d7.
PubMed 19093327Hulens M, Vansant G, Claessens AL, Lysens R, Muls E. Predictors of 6-minute walk test results in lean, obese and morbidly obese women. Scand J Med Sci Sports. 2003 Apr;13(2):98-105. doi: 10.1034/j.1600-0838.2003.10273.x.
PubMed 12641641Brown M, Sinacore DR, Host HH. The relationship of strength to function in the older adult. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:55-9. doi: 10.1093/gerona/50a.special_issue.55.
PubMed 7493219Wolfson L, Judge J, Whipple R, King M. Strength is a major factor in balance, gait, and the occurrence of falls. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:64-7. doi: 10.1093/gerona/50a.special_issue.64.
PubMed 7493221Moxley Scarborough D, Krebs DE, Harris BA. Quadriceps muscle strength and dynamic stability in elderly persons. Gait Posture. 1999 Sep;10(1):10-20. doi: 10.1016/s0966-6362(99)00018-1.
PubMed 10469937Skelton DA, Kennedy J, Rutherford OM. Explosive power and asymmetry in leg muscle function in frequent fallers and non-fallers aged over 65. Age Ageing. 2002 Mar;31(2):119-25. doi: 10.1093/ageing/31.2.119.
PubMed 11937474Capodaglio P, Vismara L, Menegoni F, Baccalaro G, Galli M, Grugni G. Strength characterization of knee flexor and extensor muscles in Prader-Willi and obese patients. BMC Musculoskelet Disord. 2009 May 6;10:47. doi: 10.1186/1471-2474-10-47.
PubMed 19419559Nocera J, Buford TW, Manini TM, Naugle K, Leeuwenburgh C, Pahor M, Perri MG, Anton SD. The impact of behavioral intervention on obesity mediated declines in mobility function: implications for longevity. J Aging Res. 2011;2011:392510. doi: 10.4061/2011/392510. Epub 2011 Oct 16.
PubMed 22013527Wakeling JM, Liphardt AM, Nigg BM. Muscle activity reduces soft-tissue resonance at heel-strike during walking. J Biomech. 2003 Dec;36(12):1761-9. doi: 10.1016/s0021-9290(03)00216-1.
PubMed 14614930Taylor WR, Heller MO, Bergmann G, Duda GN. Tibio-femoral loading during human gait and stair climbing. J Orthop Res. 2004 May;22(3):625-32. doi: 10.1016/j.orthres.2003.09.003.
PubMed 15099644Gaines JM, Talbot LA. Isokinetic strength testing in research and practice. Biol Res Nurs. 1999 Jul;1(1):57-64. doi: 10.1177/109980049900100108.
PubMed 11225298Gleeson NP, Mercer TH. The utility of isokinetic dynamometry in the assessment of human muscle function. Sports Med. 1996 Jan;21(1):18-34. doi: 10.2165/00007256-199621010-00003.
PubMed 8771283
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Body Composition and the Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04129801
- Acronym / sponsor ID
- 01038912.6.0000.0068
- Conditions
- Severe Obesity
- Keywords
- Severe obesity, Body Composition, Muscle Strength, Electrical bioimpedance analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective analysis | – | Other: Isokinetic Dynamometer, Other: BioimpedanceBioimpedance 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 40 and 60 kg/m2.
Key exclusion criteria (3 listed)
- Functional disability
- Treatment with steroid medication for any reason.
- Use of artificial devices such as an orthosis or a prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic DynamometerParticipants 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 | Prospective analysis |
| BioimpedanceBioimpedance 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). | Other | Prospective analysis |
Primary outcome
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)
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
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 (%).
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,%).
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
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
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, %)
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, %)
1 secondary outcome
Muscle strength of the lower limbs relative body weight
Time frame: 6 months and 36 months after bariatric surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 22570558Pereira-Lancha LO, Campos-Ferraz PL, Lancha AH Jr. Obesity: considerations about etiology, metabolism, and the use of experimental models. Diabetes Metab Syndr Obes. 2012;5:75-87. doi: 10.2147/DMSO.S25026. Epub 2012 Apr 10.
- Background: PubMed 15166307Okoro CA, Hootman JM, Strine TW, Balluz LS, Mokdad AH. Disability, arthritis, and body weight among adults 45 years and older. Obes Res. 2004 May;12(5):854-61. doi: 10.1038/oby.2004.103.
- Background: PubMed 10790748Syed IY, Davis BL. Obesity and osteoarthritis of the knee: hypotheses concerning the relationship between ground reaction forces and quadriceps fatigue in long-duration walking. Med Hypotheses. 2000 Feb;54(2):182-5. doi: 10.1054/mehy.1999.0013.
- Background: PubMed 19093327Anandacoomarasamy A, Fransen M, March L. Obesity and the musculoskeletal system. Curr Opin Rheumatol. 2009 Jan;21(1):71-7. doi: 10.1097/bor.0b013e32831bc0d7.
- Background: PubMed 12641641Hulens M, Vansant G, Claessens AL, Lysens R, Muls E. Predictors of 6-minute walk test results in lean, obese and morbidly obese women. Scand J Med Sci Sports. 2003 Apr;13(2):98-105. doi: 10.1034/j.1600-0838.2003.10273.x.
- Background: PubMed 7493219Brown M, Sinacore DR, Host HH. The relationship of strength to function in the older adult. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:55-9. doi: 10.1093/gerona/50a.special_issue.55.
- Background: PubMed 7493221Wolfson L, Judge J, Whipple R, King M. Strength is a major factor in balance, gait, and the occurrence of falls. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:64-7. doi: 10.1093/gerona/50a.special_issue.64.
- Background: PubMed 10469937Moxley Scarborough D, Krebs DE, Harris BA. Quadriceps muscle strength and dynamic stability in elderly persons. Gait Posture. 1999 Sep;10(1):10-20. doi: 10.1016/s0966-6362(99)00018-1.
- Background: PubMed 11937474Skelton DA, Kennedy J, Rutherford OM. Explosive power and asymmetry in leg muscle function in frequent fallers and non-fallers aged over 65. Age Ageing. 2002 Mar;31(2):119-25. doi: 10.1093/ageing/31.2.119.
- Background: PubMed 19419559Capodaglio P, Vismara L, Menegoni F, Baccalaro G, Galli M, Grugni G. Strength characterization of knee flexor and extensor muscles in Prader-Willi and obese patients. BMC Musculoskelet Disord. 2009 May 6;10:47. doi: 10.1186/1471-2474-10-47.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto de Cleva, MD Phd study chair
Clinical Hospital of University of Sao Paulo Medical School
Alexandre Gadducci, MsC principal investigator
University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Muscle strength of the lower limbs (time frame: 6 months after bariatric surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129801, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.