- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532659
Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight
February 13, 2019 updated by: Thacira Dantas Almeida Ramos, Professor Fernando Figueira Integral Medicine Institute
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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PB
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Campina Grande, PB, Brazil, 58415483
- Escola Municipal de Ensino Fundamental Governador Antônio Mariz
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Campina Grande, PB, Brazil, 58416336
- Escola Municipal de Ensino Fundamental Tiradentes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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10 minutes
|
Maximum blood flow (MF)
Time Frame: 10 minutes
|
Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).
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10 minutes
|
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).
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10 minutes
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Relationship between peak flow during PORH and resting blood flow.
Time Frame: 10 minutes
|
Continuous variable, MF / RF ratio expressed in perfusion units (PU).
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10 minutes
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PORH index
Time Frame: 10 minutes
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Scalar numerical variable related to reactive hyperemia after the arterial occlusion.
mechanism, expressed in perfusion units (PU)
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10 minutes
|
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).
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10 minutes
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Carotid Intima Media Thickness
Time Frame: 30 minutes
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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.
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30 minutes
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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.
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30 minutes
|
Cardiorespiratory Fitness - Maximum oxygen consumption
Time Frame: 10 minutes
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Numerical, continuous, expressed in liters per minute per kilogram (l/mim/kg), obtained indirectly through the 20-meter run test.
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10 minutes
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Flexibility
Time Frame: 5 minutes
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variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.
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5 minutes
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Abdominal resistance
Time Frame: 2 minutes
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numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.
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2 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nutritional status
Time Frame: 10 minutes
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measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2.
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10 minutes
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abdominal adiposity
Time Frame: 5 minutes
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measurement of abdominal circumference with inelastic tape, in centimeters.
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5 minutes
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Blood Pressure
Time Frame: 15 minutes
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measurement blood pressure (mmHg) through digital tensiometer OMRON.
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15 minutes
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Lung Function - Forced Expiratory Volume in the first second
Time Frame: 20 minutes
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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).
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20 minutes
|
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).
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20 minutes
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Strength of the inspiratory and expiratory muscles
Time Frame: 20 minutes
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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.
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20 minutes
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Fasting blood glucose
Time Frame: 5 minutes
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Continuous numeric variable expressed in mg/dL.
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5 minutes
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C-reactive protein
Time Frame: 5 minutes
|
Continuous numeric variable expressed in mg/dL.
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5 minutes
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Total cholesterol
Time Frame: 5 minutes
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Continuous numeric variable expressed in mg/dL.
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5 minutes
|
High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol
Time Frame: 5 minutes
|
Continuous numeric variable expressed in mg/dL.
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5 minutes
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Triglycerides
Time Frame: 5 minutes
|
Continuous numeric variable expressed in mg/dL.
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5 minutes
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Glycated hemoglobin A1c
Time Frame: 5 minutes
|
Continuous numeric variable expressed in percentage (%).
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5 minutes
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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.
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5 minutes
|
Quality of life assessment
Time Frame: 20 minutes
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application of validated questionnaire
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20 minutes
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Food consumption
Time Frame: 20 minutes
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application of validated questionnaire
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20 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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