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

NCT03532659 | Completed DMC

• 1 other identifier: Active video game-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Overweight and Obesity; Cardiovascular Risk Factor; Physical Activity

Keywords

adolescents; obesity; lung function; microcirculation; intima media thickness

Outcome Measures

Primary Outcomes (11)

• 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

• Maximum blood flow (MF)

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

  10 minutes

• 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

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

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

  10 minutes

• PORH index

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

  10 minutes

• 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

• 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

• 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

• 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

• Flexibility

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

  5 minutes

• Abdominal resistance

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

  2 minutes

Secondary Outcomes (15)

• nutritional status

  10 minutes

• abdominal adiposity

  5 minutes

• Blood Pressure

  15 minutes

• Lung Function - Forced Expiratory Volume in the first second

  20 minutes

• Lung Function - Total Lung Capacity

  20 minutes

Study Arms (2)

Active video game

EXPERIMENTAL

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.

Other: Active video game

control

NO INTERVENTION

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.

Interventions

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.

Active video game

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Overweight or obese adolescent
• Students enrolled in public schools

You may not qualify if:

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

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead
• Universidade Estadual da Paraíba: collaborator

Study Sites (2)

Escola Municipal de Ensino Fundamental Governador Antônio Mariz

Campina Grande, Paraíba, 58415483, Brazil

Location

Escola Municipal de Ensino Fundamental Tiradentes

Campina Grande, Paraíba, 58416336, Brazil

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Carla CM Medeiros, PhD

  Universidade Estadual da Paraíba

  PRINCIPAL INVESTIGATOR

• João Guilherme B Alves, PhD

  Professor Fernando Figueira Integral Medicine Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: May 22, 2018
• Study Start: July 2, 2018
• Primary Completion: September 21, 2018
• Study Completion: October 19, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

BR (2)