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| Name | Class |
|---|---|
| Universidad de La Frontera | OTHER |
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The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.
The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.
Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active comparator | Active Comparator | Control group with obesity under Resistant Training |
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| Experimental group with morbid obesity | Experimental | Experimental group with morbid obesity under Resistant Training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral | Other | The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Component of the Metabolic Syndrome | Change from Baseline Fasting glucose at 20-weeks of Resistant Training |
| High density lipoprotein | Component of the Metabolic Syndrome | Change from Baseline High density lipoprotein at 20-weeks of Resistant Training |
| Systolic blood pressure and diastolic blood pressure | Component of the Metabolic Syndrome | from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training |
| Waist circumference | Component of the Metabolic Syndrome | Change from Baseline Waist circumference at 20-weeks of Resistant Training |
| Triglycerides | Component of the Metabolic Syndrome | Change from Baseline Triglycerides at 20-weeks of Resistant Training |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Anthropometric | Change from Baseline Body mass index at 20-weeks of Resistant Training |
| Body mass | Anthropometric | Change from Baseline Body mass at 20-weeks of Resistant Training |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristian ALvarez, PhD | Universidad de Los Lagos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cristian ALvarez | Osorno | Llanquihue | 5290000 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31383503 | Derived | Delgado-Floody P, Alvarez C, Lusa Cadore E, Flores-Opazo M, Caamano-Navarrete F, Izquierdo M. Preventing metabolic syndrome in morbid obesity with resistance training: Reporting interindividual variability. Nutr Metab Cardiovasc Dis. 2019 Dec;29(12):1368-1381. doi: 10.1016/j.numecd.2019.07.002. Epub 2019 Jul 12. |
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The participants information will be available by e-mail according with researchers requirements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2019 | Apr 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.
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According with the availability and the feasibility of the enrolment's requirements, patients will be allocated to a control group with obesity, and another with morbid obesity.
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| Total cholesterol | Measured by plasma sample | Change from Baseline Total cholesterol at 20-weeks of Resistant Training |
| Low density lipoprotein | Measured by plasma sample | Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training |
| Six minutes walking test | Endurance performance | Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training |
| One maximum repetition of biceps curl | Strength Performance | Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training |
| Handgrip muscle strength | Muscle strength | Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |