Clinical trial NCT02406976: Effect Physical Exercise in Morbid Obesity
Official title: Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Exercise
Morbidity Obesity
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Weight Loss
timeFrame: baseline and Four months
Secondary outcomes:
measure: Metabolic Parameters (composite)
timeFrame: baseline and Four months
measure: Six minute walk test (6MWT)
timeFrame: baseline and Four months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Manoel R Trindade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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