Effect Physical Exercise in Morbid Obesity

Study Overview
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Brief Summary
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This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese

Detailed Description
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This study is a Randomized Clinical Trial, with individuals with morbid obesity, and will be consists of 3 groups: Group 1 (G1 EXERCISE): This group will participate in an physical exercise program twice a week in hospital. Group 2 (G2 - LIFESTYLE AND EXERCISE): This groups will receive the same G1 intervention associated with a weekly group followed up with techniques of cognitive behavioral therapy with a psychologist Group 3 (G3 - CONTROL): This group will keep medical appointments information and routine procedure in the hospital. Will be included in study the individuals with morbid obesity who do not have contraindications to practice low-intensity exercise. Exclusion criteria are contraindications to physical exercise, individuals with cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association), orthopedic problems, severe retinopathy, severe neuropathy, drug addicts and severe mental illness, metabolic or blood pressure decompensated.

Official Title
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Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity

Conditions
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Morbid Obesity

Intervention / Treatment
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* Other: G1 -Exercise
* Behavioral: G2- Exercise and Lifestyle
* Other: G3- Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with morbid obesity Individuals do not have contraindications to practice low-intensity exercise. Exclusion Criteria: Contraindications to physical exercise Cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association) Orthopedic problems Severe retinopathy Severe neuropathy Drug addicts and severe mental illness High blood pressure or metabolic decompensation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G1- EXERCISE<br>The group will Participate in an physical exercise program twice a week. This program consists of 20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises. | Other: G1 -Exercise<br>* 20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises. Furthermore the similar treatment to G3.<br>Other: G3- Control<br>* Routine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention.<br>|
| Experimental: G2- EXERCISE AND LIFESTYLE<br>This groups will receive the same intervention of G1 group, associated with the weekly group with a psychologist. These groups worked techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors, as well as the reduction or elimination of undesirable conduct. | Behavioral: G2- Exercise and Lifestyle<br>* Exercise more techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors and the reduction or elimination of undesirable conduct. Furthermore the similar treatment to G3.<br>Other: G3- Control<br>* Routine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention.<br>|
| Active Comparator: G3- CONTROL<br>This group will keep the routine treatment in outpatient of bariatric surgery. This treatment consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention. | Other: G3- Control<br>* Routine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight Loss |  | baseline and Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Parameters (composite) | Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months). | baseline and Four months | 
| Six minute walk test (6MWT) | Functional capacity will be evaluated using the six minute walk test (6MWT) | baseline and Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Morbidity Obesity