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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532659
• Other study ID #: Active video game-1
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: February 2019
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 19, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Overweight
• Overweight and Obesity
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Brazil	Escola Municipal de Ensino Fundamental Governador Antônio Mariz	Campina Grande	PB
Brazil	Escola Municipal de Ensino Fundamental Tiradentes	Campina Grande	PB

Sponsors (2)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute	Universidade Estadual da Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum blood flow (MF)	Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).	10 minutes
Primary	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
Primary	Relationship between peak flow during PORH and resting blood flow.	Continuous variable, MF / RF ratio expressed in perfusion units (PU).	10 minutes
Primary	PORH index	Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)	10 minutes
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Flexibility	variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.	5 minutes
Primary	Abdominal resistance	numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.	2 minutes
Secondary	nutritional status	measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2.	10 minutes
Secondary	abdominal adiposity	measurement of abdominal circumference with inelastic tape, in centimeters.	5 minutes
Secondary	Blood Pressure	measurement blood pressure (mmHg) through digital tensiometer OMRON.	15 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	Fasting blood glucose	Continuous numeric variable expressed in mg/dL.	5 minutes
Secondary	C-reactive protein	Continuous numeric variable expressed in mg/dL.	5 minutes
Secondary	Total cholesterol	Continuous numeric variable expressed in mg/dL.	5 minutes
Secondary	High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol	Continuous numeric variable expressed in mg/dL.	5 minutes
Secondary	Triglycerides	Continuous numeric variable expressed in mg/dL.	5 minutes
Secondary	Glycated hemoglobin A1c	Continuous numeric variable expressed in percentage (%).	5 minutes
Secondary	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
Secondary	Quality of life assessment	application of validated questionnaire	20 minutes
Secondary	Food consumption	application of validated questionnaire	20 minutes