Effect Physical Exercise in Morbid Obesity

Not Applicable

• Conditions: Morbid Obesity

• 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Primary Completion: 2015-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Weight Loss	baseline and Four months

Secondary Outcome Measures

Name	Time	Method
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).
Six minute walk test (6MWT)	baseline and Four months	Functional capacity will be evaluated using the six minute walk test (6MWT)

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil