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Completed

NCT Number: NCT03532659

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

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Cardiovascular Risk Factor Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Municipal de Ensino Fundamental Governador Antônio Mariz, Campina Grande, Paraíba, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active video game

Other

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 outcomes

  1. 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).

  2. Maximum blood flow (MF)

    Time frame: 10 minutes

    Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).

  3. 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).

  4. Relationship between peak flow during PORH and resting blood flow.

    Time frame: 10 minutes

    Continuous variable, MF / RF ratio expressed in perfusion units (PU).

  5. PORH index

    Time frame: 10 minutes

    Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. Flexibility

    Time frame: 5 minutes

    variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.

  11. 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 outcomes

  1. nutritional status

    Time frame: 10 minutes

    measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2.

  2. abdominal adiposity

    Time frame: 5 minutes

    measurement of abdominal circumference with inelastic tape, in centimeters.

  3. Blood Pressure

    Time frame: 15 minutes

    measurement blood pressure (mmHg) through digital tensiometer OMRON.

  4. 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).

  5. 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).

  6. 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.

  7. Fasting blood glucose

    Time frame: 5 minutes

    Continuous numeric variable expressed in mg/dL.

  8. C-reactive protein

    Time frame: 5 minutes

    Continuous numeric variable expressed in mg/dL.

  9. Total cholesterol

    Time frame: 5 minutes

    Continuous numeric variable expressed in mg/dL.

  10. High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol

    Time frame: 5 minutes

    Continuous numeric variable expressed in mg/dL.

  11. Triglycerides

    Time frame: 5 minutes

    Continuous numeric variable expressed in mg/dL.

  12. Glycated hemoglobin A1c

    Time frame: 5 minutes

    Continuous numeric variable expressed in percentage (%).

  13. 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.

  14. Quality of life assessment

    Time frame: 20 minutes

    application of validated questionnaire

  15. Food consumption

    Time frame: 20 minutes

    application of validated questionnaire

Sponsors and collaborators

Lead sponsor

Professor Fernando Figueira Integral Medicine Institute

Other

Collaborators

  • Universidade Estadual da Paraíba

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 22, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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