Effect Physical Exercise in Morbid Obesity
- Conditions
- Morbid Obesity
- Interventions
- Other: G1 -ExerciseBehavioral: G2- Exercise and LifestyleOther: G3- Control
- Registration Number
- NCT02406976
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
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
This study is a Randomized Clinical Trial, with individuals with morbid obesity, and will be consists of 3 groups:
1. Group 1 (G1 EXERCISE): This group will participate in an physical exercise program twice a week in hospital.
2. 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
3. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Individuals with morbid obesity
- Individuals do not have contraindications to practice low-intensity exercise.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G1- EXERCISE G1 -Exercise 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. G1- EXERCISE G3- Control 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. G2- EXERCISE AND LIFESTYLE G2- Exercise and Lifestyle 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. G2- EXERCISE AND LIFESTYLE G3- Control 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. G3- CONTROL G3- Control 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.
- Primary Outcome Measures
Name Time Method Change in Weight Loss baseline and Four months
- Secondary Outcome Measures
Name Time Method Six minute walk test (6MWT) baseline and Four months Functional capacity will be evaluated using the six minute walk test (6MWT)
Metabolic Parameters (composite) baseline and Four months Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months).
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil