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

Primary Purpose

Overweight and Obesity, Cardiovascular Risk Factor, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active video game
Sponsored by
Professor Fernando Figueira Integral Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring adolescents, obesity, lung function, microcirculation, intima media thickness

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Escola Municipal de Ensino Fundamental Governador Antônio Mariz
  • Escola Municipal de Ensino Fundamental Tiradentes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active video game

control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Maximum blood flow (MF)
Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).
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).
Relationship between peak flow during PORH and resting blood flow.
Continuous variable, MF / RF ratio expressed in perfusion units (PU).
PORH index
Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)
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).
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.
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.
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.
Flexibility
variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.
Abdominal resistance
numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2018
Last Updated
February 13, 2019
Sponsor
Professor Fernando Figueira Integral Medicine Institute
Collaborators
Universidade Estadual da Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT03532659
Brief Title
Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight
Official Title
Impact of Active Video Game Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight: Randomized Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
October 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Professor Fernando Figueira Integral Medicine Institute
Collaborators
Universidade Estadual da Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Cardiovascular Risk Factor, Physical Activity
Keywords
adolescents, obesity, lung function, microcirculation, intima media thickness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention with two comparison groups. The control or experimental group will be randomly defined by school "Experimental" group: will perform physical activity through the use of the active videogame associated with a gamification strategy three times a week for 50 minutes for a period of 8 weeks. Control group: there will be no intervention proposal, only used for data comparison.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active video game
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active video game
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microcirculatory blood flow during rest (RF)
Description
Variable measured in perfusion units (PU), obtained during the first five minutes of the microcirculation evaluation protocol by Cutaneous Laser Doppler Flowmetry (LDF).
Time Frame
10 minutes
Title
Maximum blood flow (MF)
Description
Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).
Time Frame
10 minutes
Title
Area of hyperemia
Description
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).
Time Frame
10 minutes
Title
Relationship between peak flow during PORH and resting blood flow.
Description
Continuous variable, MF / RF ratio expressed in perfusion units (PU).
Time Frame
10 minutes
Title
PORH index
Description
Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)
Time Frame
10 minutes
Title
Occlusion area
Description
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).
Time Frame
10 minutes
Title
Carotid Intima Media Thickness
Description
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.
Time Frame
30 minutes
Title
Femoral Intima Media Thickness
Description
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.
Time Frame
30 minutes
Title
Cardiorespiratory Fitness - Maximum oxygen consumption
Description
Numerical, continuous, expressed in liters per minute per kilogram (l/mim/kg), obtained indirectly through the 20-meter run test.
Time Frame
10 minutes
Title
Flexibility
Description
variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.
Time Frame
5 minutes
Title
Abdominal resistance
Description
numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
nutritional status
Description
measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2.
Time Frame
10 minutes
Title
abdominal adiposity
Description
measurement of abdominal circumference with inelastic tape, in centimeters.
Time Frame
5 minutes
Title
Blood Pressure
Description
measurement blood pressure (mmHg) through digital tensiometer OMRON.
Time Frame
15 minutes
Title
Lung Function - Forced Expiratory Volume in the first second
Description
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).
Time Frame
20 minutes
Title
Lung Function - Total Lung Capacity
Description
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).
Time Frame
20 minutes
Title
Strength of the inspiratory and expiratory muscles
Description
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.
Time Frame
20 minutes
Title
Fasting blood glucose
Description
Continuous numeric variable expressed in mg/dL.
Time Frame
5 minutes
Title
C-reactive protein
Description
Continuous numeric variable expressed in mg/dL.
Time Frame
5 minutes
Title
Total cholesterol
Description
Continuous numeric variable expressed in mg/dL.
Time Frame
5 minutes
Title
High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol
Description
Continuous numeric variable expressed in mg/dL.
Time Frame
5 minutes
Title
Triglycerides
Description
Continuous numeric variable expressed in mg/dL.
Time Frame
5 minutes
Title
Glycated hemoglobin A1c
Description
Continuous numeric variable expressed in percentage (%).
Time Frame
5 minutes
Title
Low density lipoprotein (LDL) cholesterol
Description
Continuous numeric variable obtained by the Friedewald formula= Cholesterol Total - (High Density Lipoprotein + Triglyderides/5), expressed in mg/dL.
Time Frame
5 minutes
Title
Quality of life assessment
Description
application of validated questionnaire
Time Frame
20 minutes
Title
Food consumption
Description
application of validated questionnaire
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla CM Medeiros, PhD
Organizational Affiliation
Universidade Estadual da Paraíba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
João Guilherme B Alves, PhD
Organizational Affiliation
Professor Fernando Figueira Integral Medicine Institute
Official's Role
Study Director
Facility Information:
Facility Name
Escola Municipal de Ensino Fundamental Governador Antônio Mariz
City
Campina Grande
State/Province
PB
ZIP/Postal Code
58415483
Country
Brazil
Facility Name
Escola Municipal de Ensino Fundamental Tiradentes
City
Campina Grande
State/Province
PB
ZIP/Postal Code
58416336
Country
Brazil

12. IPD Sharing Statement

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

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