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

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Overweight and Obesity; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Active video game

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PB
    • Campina Grande, PB, Brazil, 58415483
      • Escola Municipal de Ensino Fundamental Governador Antônio Mariz
    • Campina Grande, PB, Brazil, 58416336
      • Escola Municipal de Ensino Fundamental Tiradentes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microcirculatory blood flow during rest (RF)	Variable measured in perfusion units (PU), obtained during the first five minutes of the microcirculation evaluation protocol by Cutaneous Laser Doppler Flowmetry (LDF).	10 minutes
Maximum blood flow (MF)	Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).	10 minutes
Area of hyperemia	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).	10 minutes
Relationship between peak flow during PORH and resting blood flow.	Continuous variable, MF / RF ratio expressed in perfusion units (PU).	10 minutes
PORH index	Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)	10 minutes
Occlusion area	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).	10 minutes
Carotid Intima Media Thickness	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.	30 minutes
Femoral Intima Media Thickness	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.	30 minutes
Cardiorespiratory Fitness - Maximum oxygen consumption	Numerical, continuous, expressed in liters per minute per kilogram (l/mim/kg), obtained indirectly through the 20-meter run test.	10 minutes
Flexibility	variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.	5 minutes
Abdominal resistance	numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional status	measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2.	10 minutes
abdominal adiposity	measurement of abdominal circumference with inelastic tape, in centimeters.	5 minutes
Blood Pressure	measurement blood pressure (mmHg) through digital tensiometer OMRON.	15 minutes
Lung Function - Forced Expiratory Volume in the first second	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).	20 minutes
Lung Function - Total Lung Capacity	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).	20 minutes
Strength of the inspiratory and expiratory muscles	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.	20 minutes
Fasting blood glucose	Continuous numeric variable expressed in mg/dL.	5 minutes
C-reactive protein	Continuous numeric variable expressed in mg/dL.	5 minutes
Total cholesterol	Continuous numeric variable expressed in mg/dL.	5 minutes
High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol	Continuous numeric variable expressed in mg/dL.	5 minutes
Triglycerides	Continuous numeric variable expressed in mg/dL.	5 minutes
Glycated hemoglobin A1c	Continuous numeric variable expressed in percentage (%).	5 minutes
Low density lipoprotein (LDL) cholesterol	Continuous numeric variable obtained by the Friedewald formula= Cholesterol Total - (High Density Lipoprotein + Triglyderides/5), expressed in mg/dL.	5 minutes
Quality of life assessment	application of validated questionnaire	20 minutes
Food consumption	application of validated questionnaire	20 minutes

Collaborators and Investigators

• Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Collaborators: Universidade Estadual da Paraiba
• Investigators: Principal Investigator: Carla CM Medeiros, PhD, Universidade Estadual da Paraiba; Study Director: João Guilherme B Alves, PhD, Professor Fernando Figueira Integral Medicine Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: May 19, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: lung function; obesity; microcirculation; adolescents; intima media thickness
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: Active video game-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No