Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 21, 2018

Interventions

  • Other: Active video game
    • Among the 20 municipal schools, two will be selected between those with 298 or more students (corresponding to the third quartile of the number of students per school). Next will be selected the school in which the adolescents will be submitted to intervention, and the students from the other school will be control. The intervention will aim to promote physical exercise through active video game XBOX 360 with Kinect. The game selected will be Just Dance, to allow the participation of up to four students at the same time. In addition, a gamification protocol will be performed to increase the adolescents engagement in the exercise.

Arms, Groups and Cohorts

  • Experimental: Active video game
    • 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.
  • No Intervention: control
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Microcirculatory blood flow during rest (RF)
    • Time Frame: 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).
  • Maximum blood flow (MF)
    • Time Frame: 10 minutes
    • Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).
  • Area of hyperemia
    • Time Frame: 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.
    • Time Frame: 10 minutes
    • Continuous variable, MF / RF ratio expressed in perfusion units (PU).
  • PORH index
    • Time Frame: 10 minutes
    • Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)
  • Occlusion area
    • Time Frame: 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).
  • Carotid Intima Media Thickness
    • Time Frame: 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.
  • Femoral Intima Media Thickness
    • Time Frame: 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.
  • Cardiorespiratory Fitness – Maximum oxygen consumption
    • Time Frame: 10 minutes
    • Numerical, continuous, expressed in liters per minute per kilogram (l/mim/kg), obtained indirectly through the 20-meter run test.
  • Flexibility
    • Time Frame: 5 minutes
    • variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.
  • Abdominal resistance
    • Time Frame: 2 minutes
    • numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.

Secondary Measures

  • nutritional status
    • Time Frame: 10 minutes
    • measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2.
  • abdominal adiposity
    • Time Frame: 5 minutes
    • measurement of abdominal circumference with inelastic tape, in centimeters.
  • Blood Pressure
    • Time Frame: 15 minutes
    • measurement blood pressure (mmHg) through digital tensiometer OMRON.
  • Lung Function – Forced Expiratory Volume in the first second
    • Time Frame: 20 minutes
    • Evaluated by spirometry, with a computerized ultrasonic portable spirometer, with flow sensor, Easy One® brand, with internal Winspiro Software upgrade version 1.04 for connection to computer. The course will provide the values of Forced Expiratory Volume in the first second expressed in liters (l) and in percentage of the predicted value individually (%pred).
  • Lung Function – Total Lung Capacity
    • Time Frame: 20 minutes
    • Evaluated by spirometry, with a computerized ultrasonic portable spirometer, with flow sensor, Easy One® brand, with internal Winspiro Software upgrade version 1.04 for connection to computer. The course will provide the values of Total Lung Capacity expressed in liters (l) and in percentage of the predicted value individually (%pred).
  • Strength of the inspiratory and expiratory muscles
    • Time Frame: 20 minutes
    • Evaluated by digital manovacuometry, through a digital manovacuometer MVD300, will be obtained the measurement of respiratory maximum static pressures, maximum inspiratory pressure regarding inspiratory muscle strength and maximum expiratory pressure regarding the expiratory muscles. Both will be expressed in cmH2O.
  • Fasting blood glucose
    • Time Frame: 5 minutes
    • Continuous numeric variable expressed in mg/dL.
  • C-reactive protein
    • Time Frame: 5 minutes
    • Continuous numeric variable expressed in mg/dL.
  • Total cholesterol
    • Time Frame: 5 minutes
    • Continuous numeric variable expressed in mg/dL.
  • High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol
    • Time Frame: 5 minutes
    • Continuous numeric variable expressed in mg/dL.
  • Triglycerides
    • Time Frame: 5 minutes
    • Continuous numeric variable expressed in mg/dL.
  • Glycated hemoglobin A1c
    • Time Frame: 5 minutes
    • Continuous numeric variable expressed in percentage (%).
  • Low density lipoprotein (LDL) cholesterol
    • Time Frame: 5 minutes
    • Continuous numeric variable obtained by the Friedewald formula= Cholesterol Total – (High Density Lipoprotein + Triglyderides/5), expressed in mg/dL.
  • Quality of life assessment
    • Time Frame: 20 minutes
    • application of validated questionnaire
  • Food consumption
    • Time Frame: 20 minutes
    • application of validated questionnaire

Participating in This Clinical Trial

Inclusion Criteria

  • Overweight or obese adolescent
  • Students enrolled in public schools

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Professor Fernando Figueira Integral Medicine Institute
  • Collaborator
    • Universidade Estadual da Paraíba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thacira Dantas Almeida Ramos, Doctorate – Professor Fernando Figueira Integral Medicine Institute
  • Overall Official(s)
    • Carla CM Medeiros, PhD, Principal Investigator, Universidade Estadual da Paraíba
    • João Guilherme B Alves, PhD, Study Director, Professor Fernando Figueira Integral Medicine Institute

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