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Overweight and ObesityNCT03532659

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

A study testing Active video game in people with Overweight and Obesity and Cardiovascular Risk Factor, run by Professor Fernando Figueira Integral Medicine Institute at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 16 years
What is being tested?
Active video game
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesBrazil
Study dates
2 Jul 2018to 19 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Overweight or obese adolescent
  • Students enrolled in public schools

Who cannot join

  • Motor, cognitive or pulmonary limitation
  • Genetic syndrome
  • Pregnancy
  • Use of medication that changes the lipid or glucose profile
  • Not being treated for overweight

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Escola Municipal de Ensino Fundamental Governador Antônio Mariz

    Campina Grande, Paraíba, 58415483

  • Escola Municipal de Ensino Fundamental Tiradentes

    Campina Grande, Paraíba, 58416336

Other trials in Brazil

About this study

Official title: 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.

Being tested
Active video game
Keywords
adolescents, obesity, lung function, microcirculation, intima media thickness
Medical subject headings
Overweight, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active video gameOther

    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.

Study groups in NCT03532659
Study groupRoleWhat they receive
Active video gameExperimentalThe 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.
Receives: Other: Active video game
controlNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 10 minutes

  2. Maximum blood flow (MF)

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

    Measured: 10 minutes

  3. 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).

    Measured: 10 minutes

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

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

    Measured: 10 minutes

  5. PORH index

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

    Measured: 10 minutes

  6. 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).

    Measured: 10 minutes

  7. 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.

    Measured: 30 minutes

  8. 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.

    Measured: 30 minutes

  9. 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.

    Measured: 10 minutes

  10. Flexibility

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

    Measured: 5 minutes

  11. Abdominal resistance

    numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.

    Measured: 2 minutes

Secondary outcomes (15)

  1. nutritional status

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

    Measured: 10 minutes

  2. abdominal adiposity

    measurement of abdominal circumference with inelastic tape, in centimeters.

    Measured: 5 minutes

  3. Blood Pressure

    measurement blood pressure (mmHg) through digital tensiometer OMRON.

    Measured: 15 minutes

  4. 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).

    Measured: 20 minutes

  5. 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).

    Measured: 20 minutes

  6. 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.

    Measured: 20 minutes

  7. Fasting blood glucose

    Continuous numeric variable expressed in mg/dL.

    Measured: 5 minutes

  8. C-reactive protein

    Continuous numeric variable expressed in mg/dL.

    Measured: 5 minutes

  9. Total cholesterol

    Continuous numeric variable expressed in mg/dL.

    Measured: 5 minutes

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

    Continuous numeric variable expressed in mg/dL.

    Measured: 5 minutes

  11. Triglycerides

    Continuous numeric variable expressed in mg/dL.

    Measured: 5 minutes

  12. Glycated hemoglobin A1c

    Continuous numeric variable expressed in percentage (%).

    Measured: 5 minutes

  13. Low density lipoprotein (LDL) cholesterol

    Continuous numeric variable obtained by the Friedewald formula= Cholesterol Total - (High Density Lipoprotein + Triglyderides/5), expressed in mg/dL.

    Measured: 5 minutes

  14. Quality of life assessment

    application of validated questionnaire

    Measured: 20 minutes

  15. Food consumption

    application of validated questionnaire

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start2 Jul 2018
  3. Primary completion21 Sep 2018
  4. Study completion19 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532659
Sponsor's protocol ID
Active video game-1
Status last verified
Feb 2019
First submitted
15 Mar 2018
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active video game in people with Overweight and Obesity and Cardiovascular Risk Factor, run by Professor Fernando Figueira Integral Medicine Institute at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microcirculatory blood flow during rest (RF) (time frame: 10 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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