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临床试验/NCT03532659
NCT03532659已完成不适用

Impact of Active Video Game Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight: Randomized Intervention Study

Professor Fernando Figueira Integral Medicine Institute4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年7月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
4
主要终点
Maximum blood flow (MF)

研究概览

简要总结

This study evaluates the effects of physical exercise through active videogame in the microcirculation, macrocirculation, cardiorespiratory function and physical fitness in overweight adolescents. For that, they will be randomized into two groups, one being a control group and the other intervention group. The randomization will be made by school. The intervention group will perform the physical exercise through the active video game, three times a week, for 50 minutes, during 8 weeks. Reassessments will be performed before and after the intervention to evaluate the outcome variables.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Overweight or obese adolescent
  • Students enrolled in public schools

排除标准

  • Motor, cognitive or pulmonary limitation
  • Genetic syndrome
  • Pregnancy
  • Use of medication that changes the lipid or glucose profile
  • Not being treated for overweight

研究组 & 干预措施

Active video game

Experimental

The adolescents will be submitted to physical activity with active video game for 50 minutes, 3 times a week, for a period of eight weeks. The XBOX360® platform will be used with the Kinect accessory (Microsoft®) and Just Dance will be the selected game. The music used for intervention will be previously selected, including those that can lead to moderate intensity, and assembled in blocks of 10. For each week, a new block and challenges must be elaborated to increase the motivation to carry out the physical activity.

干预措施: Active video game (Other)

control

No Intervention

A follow-up will be done for eight weeks to compare the variables. The adolescents in this group will be interviewed monthly to detect changes in eating habits and lifestyle.

结局指标

主要结局

Maximum blood flow (MF)

时间窗: 10 minutes

Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).

Microcirculatory blood flow during rest (RF)

时间窗: 10 minutes

Variable measured in perfusion units (PU), obtained during the first five minutes of the microcirculation evaluation protocol by Cutaneous Laser Doppler Flowmetry (LDF).

Area of hyperemia

时间窗: 10 minutes

Scalar numerical variable corresponding to the geometric area related to the process of reflex hyperemia after the mechanism of arterial occlusion, expressed in perfusion units (PU).

Relationship between peak flow during PORH and resting blood flow.

时间窗: 10 minutes

Continuous variable, MF / RF ratio expressed in perfusion units (PU).

PORH index

时间窗: 10 minutes

Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)

Occlusion area

时间窗: 10 minutes

Scalar numerical variable corresponding to the geometric area related to the region without reflex hyperemia after the arterial occlusion mechanism, expressed in perfusion units (PU).

Femoral Intima Media Thickness

时间窗: 30 minutes

Variable measured in millimeters, obtained by the maximum value of 3 measurements made in the right femoral artery and 3 measurements in the left femoral artery. Performed with a portable device (General Eletric®, LogicE® model), with a high definition linear transducer.

Carotid Intima Media Thickness

时间窗: 30 minutes

Variable measured in millimeters, obtained by the maximum value of 3 measurements performed in the right common carotid artery and 3 measurements in the left common carotid artery. Performed with a portable device (General Eletric®, LogicE® model), with a high definition linear transducer.

Cardiorespiratory Fitness - Maximum oxygen consumption

时间窗: 10 minutes

Numerical, continuous, expressed in liters per minute per kilogram (l/mim/kg), obtained indirectly through the 20-meter run test.

Flexibility

时间窗: 5 minutes

variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.

Abdominal resistance

时间窗: 2 minutes

numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.

次要结局

  • Triglycerides(5 minutes)
  • nutritional status(10 minutes)
  • Blood Pressure(15 minutes)
  • abdominal adiposity(5 minutes)
  • Lung Function - Forced Expiratory Volume in the first second(20 minutes)
  • Lung Function - Total Lung Capacity(20 minutes)
  • Strength of the inspiratory and expiratory muscles(20 minutes)
  • Fasting blood glucose(5 minutes)
  • C-reactive protein(5 minutes)
  • Total cholesterol(5 minutes)
  • High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol(5 minutes)
  • Glycated hemoglobin A1c(5 minutes)
  • Low density lipoprotein (LDL) cholesterol(5 minutes)
  • Quality of life assessment(20 minutes)
  • Food consumption(20 minutes)

研究者

发起方
Professor Fernando Figueira Integral Medicine Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thacira Dantas Almeida Ramos

Doctorate

Professor Fernando Figueira Integral Medicine Institute

研究点 (4)

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