Clinical trial NCT03532659: Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight
Official title: Impact of Active Video Game Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight: Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Cardiovascular Risk Factor
Physical Activity
Keywords: adolescents
obesity
lung function
microcirculation
intima media thickness
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Universidade Estadual da Paraíba
First posted: 2018-05-22
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Microcirculatory blood flow during rest (RF)
timeFrame: 10 minutes
measure: Maximum blood flow (MF)
timeFrame: 10 minutes
measure: Area of hyperemia
timeFrame: 10 minutes
measure: Relationship between peak flow during PORH and resting blood flow.
timeFrame: 10 minutes
measure: PORH index
timeFrame: 10 minutes
measure: Occlusion area
timeFrame: 10 minutes
measure: Carotid Intima Media Thickness
timeFrame: 30 minutes
measure: Femoral Intima Media Thickness
timeFrame: 30 minutes
measure: Cardiorespiratory Fitness - Maximum oxygen consumption
timeFrame: 10 minutes
measure: Flexibility
timeFrame: 5 minutes
measure: Abdominal resistance
timeFrame: 2 minutes
Secondary outcomes:
measure: nutritional status
timeFrame: 10 minutes
measure: abdominal adiposity
timeFrame: 5 minutes
measure: Blood Pressure
timeFrame: 15 minutes
measure: Lung Function - Forced Expiratory Volume in the first second
timeFrame: 20 minutes
measure: Lung Function - Total Lung Capacity
timeFrame: 20 minutes
measure: Strength of the inspiratory and expiratory muscles
timeFrame: 20 minutes
measure: Fasting blood glucose
timeFrame: 5 minutes
measure: C-reactive protein
timeFrame: 5 minutes
measure: Total cholesterol
timeFrame: 5 minutes
measure: High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol
timeFrame: 5 minutes
measure: Triglycerides
timeFrame: 5 minutes
measure: Glycated hemoglobin A1c
timeFrame: 5 minutes
measure: Low density lipoprotein (LDL) cholesterol
timeFrame: 5 minutes
measure: Quality of life assessment
timeFrame: 20 minutes
measure: Food consumption
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Campina Grande
country: Brazil
facility: Escola Municipal de Ensino Fundamental Governador Antônio Mariz
state: PB
city: Campina Grande
country: Brazil
facility: Escola Municipal de Ensino Fundamental Tiradentes
state: PB
Study officials:
affiliation: Universidade Estadual da Paraíba
name: Carla CM Medeiros, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor Fernando Figueira Integral Medicine Institute
name: João Guilherme B Alves, PhD
role: STUDY_DIRECTOR
References: