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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03532659
Other study ID # Active video game-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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