Effect Physical Exercise in Morbid Obesity
Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMarch 14, 2017
March 1, 2017
5.3 years
March 30, 2015
March 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Weight Loss
baseline and Four months
Secondary Outcomes (2)
Metabolic Parameters (composite)
baseline and Four months
Six minute walk test (6MWT)
baseline and Four months
Study Arms (3)
G1- EXERCISE
EXPERIMENTALThe 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.
G2- EXERCISE AND LIFESTYLE
EXPERIMENTALThis 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.
G3- CONTROL
ACTIVE COMPARATORThis 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Individuals with morbid obesity
- Individuals do not have contraindications to practice low-intensity exercise.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 903, Brazil
Related Publications (2)
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.
PMID: 21881816BACKGROUNDFonseca Jr SJ, et al. Exercício Físico e Obesidade Mórbida: Uma Revisão Sistemática. ABCD Arq Bras Cir Dig 2013;26(Suplemento 1):67-73
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manoel R Trindade, PhD
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2015
First Posted
April 2, 2015
Study Start
August 1, 2010
Primary Completion
November 1, 2015
Study Completion
November 1, 2018
Last Updated
March 14, 2017
Record last verified: 2017-03