Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Weight Loss
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: G1 -Exercise (Other)
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.
Intervention: G3- Control (Other)
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.
Intervention: G2- Exercise and Lifestyle (Behavioral)
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.
Intervention: G3- Control (Other)
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.
Intervention: G3- Control (Other)
Outcomes
Primary Outcomes
Change in Weight Loss
Time Frame: baseline and Four months
Secondary Outcomes
- Six minute walk test (6MWT)(baseline and Four months)
- Metabolic Parameters (composite)(baseline and Four months)