Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatments g1 -exercise, g2- exercise and lifestyle, g3- control
Sponsor Hospital de Clinicas de Porto Alegre
Start date August 2010
End date December 2015
Trial size 60 participants
Trial identifier NCT02406976, 10-0328

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
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.
g3- control
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.
(Experimental)
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
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.
g3- control
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.
(Active Comparator)
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.
g3- control
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.

Primary Outcomes

Measure
Change in Weight Loss
time frame: baseline and Four months

Secondary Outcomes

Measure
Metabolic Parameters (composite)
time frame: baseline and Four months
Six minute walk test (6MWT)
time frame: baseline and Four months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
Principal investigator Manoel R Trindade, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.