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Effect Physical Exercise in Morbid Obesity

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
G1 -Exercise
G2- Exercise and Lifestyle
G3- Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Exercise, Morbidity Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

G1- EXERCISE

G2- EXERCISE AND LIFESTYLE

G3- CONTROL

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Weight Loss

Secondary Outcome Measures

Metabolic Parameters (composite)
Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months).
Six minute walk test (6MWT)
Functional capacity will be evaluated using the six minute walk test (6MWT)

Full Information

First Posted
March 30, 2015
Last Updated
March 10, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02406976
Brief Title
Effect Physical Exercise in Morbid Obesity
Official Title
Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Exercise, Morbidity Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G1- EXERCISE
Arm Type
Experimental
Arm 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.
Arm Title
G2- EXERCISE AND LIFESTYLE
Arm Type
Experimental
Arm 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.
Arm Title
G3- CONTROL
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
G1 -Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
G2- Exercise and Lifestyle
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
G3- Control
Intervention Description
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 Outcome Measure Information:
Title
Change in Weight Loss
Time Frame
baseline and Four months
Secondary Outcome Measure Information:
Title
Metabolic Parameters (composite)
Description
Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months).
Time Frame
baseline and Four months
Title
Six minute walk test (6MWT)
Description
Functional capacity will be evaluated using the six minute walk test (6MWT)
Time Frame
baseline and Four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoel R Trindade, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035 903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21881816
Citation
Marcon ER, Gus I, Neumann CR. [Impact of a minimum program of supervised exercises in the cardiometabolic risk in patients with morbid obesity]. Arq Bras Endocrinol Metabol. 2011 Jun;55(5):331-8. doi: 10.1590/s0004-27302011000500006. Portuguese.
Results Reference
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Citation
Fonseca Jr SJ, et al. Exercício Físico e Obesidade Mórbida: Uma Revisão Sistemática. ABCD Arq Bras Cir Dig 2013;26(Suplemento 1):67-73
Results Reference
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Effect Physical Exercise in Morbid Obesity

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