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临床试验/NCT02406976
NCT02406976Unknown不适用

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

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change in Weight Loss

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with morbid obesity
  • Individuals do not have contraindications to practice low-intensity exercise.

排除标准

  • 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

结局指标

主要结局

Change in Weight Loss

时间窗: baseline and Four months

次要结局

  • Six minute walk test (6MWT)(baseline and Four months)
  • Metabolic Parameters (composite)(baseline and Four months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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