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Clinical Trials/NCT02406976
NCT02406976
Unknown
Not Applicable

Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity

Hospital de Clinicas de Porto Alegre1 site in 1 country60 target enrollmentAugust 2010
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
60
Locations
1
Primary Endpoint
Change in Weight Loss
Last Updated
9 years ago

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: 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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
November 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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