Effect Physical Exercise in Morbid Obesity

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Morbid Obesity

Treatments: Other: G1 -Exercise; Other: G3- Control; Behavioral: G2- Exercise and Lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT02406976

10-0328

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

G1- EXERCISE

Experimental group

Description:

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.

Treatment:

Other: G3- Control

Other: G1 -Exercise

G2- EXERCISE AND LIFESTYLE

Experimental group

Description:

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.

Treatment:

Other: G3- Control

Behavioral: G2- Exercise and Lifestyle

G3- CONTROL

Active Comparator group

Description:

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.

Treatment:

Other: G3- Control