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Effect Physical Exercise in Morbid Obesity

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ClinicalTrials.gov Identifier: NCT02406976
Recruitment Status : Unknown
Verified March 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Morbid Obesity Other: G1 -Exercise Behavioral: G2- Exercise and Lifestyle Other: G3- Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
Study Start Date : August 2010
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: G1- EXERCISE
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.
Other: 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.


Other: 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: G2- EXERCISE AND LIFESTYLE

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.

Behavioral: 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.


Other: 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: G3- CONTROL
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.
Other: 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 Outcome Measures :
  1. Change in Weight Loss [ Time Frame: baseline and Four months ]

Secondary Outcome Measures :
  1. Metabolic Parameters (composite) [ Time Frame: baseline and Four months ]
    Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months).

  2. Six minute walk test (6MWT) [ Time Frame: baseline and Four months ]
    Functional capacity will be evaluated using the six minute walk test (6MWT)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406976


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035 903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Manoel R Trindade, PhD Hospital de Clinicas de Porto Alegre

Publications:
Fonseca Jr SJ, et al. Exercício Físico e Obesidade Mórbida: Uma Revisão Sistemática. ABCD Arq Bras Cir Dig 2013;26(Suplemento 1):67-73

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02406976     History of Changes
Other Study ID Numbers: 10-0328
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Exercise
Morbidity Obesity
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms