Physical Activity Clinical Trial
Official title:
Impact of Active Video Game Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight: Randomized Intervention Study
Verified date | February 2019 |
Source | Professor Fernando Figueira Integral Medicine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 19, 2018 |
Est. primary completion date | September 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Escola Municipal de Ensino Fundamental Governador Antônio Mariz | Campina Grande | PB |
Brazil | Escola Municipal de Ensino Fundamental Tiradentes | Campina Grande | PB |
Lead Sponsor | Collaborator |
---|---|
Professor Fernando Figueira Integral Medicine Institute | Universidade Estadual da Paraíba |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Maximum blood flow (MF) | Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU). | 10 minutes | |
Primary | 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 | |
Primary | Relationship between peak flow during PORH and resting blood flow. | Continuous variable, MF / RF ratio expressed in perfusion units (PU). | 10 minutes | |
Primary | PORH index | Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU) | 10 minutes | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Flexibility | variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test. | 5 minutes | |
Primary | Abdominal resistance | numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test. | 2 minutes | |
Secondary | nutritional status | measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m^2. | 10 minutes | |
Secondary | abdominal adiposity | measurement of abdominal circumference with inelastic tape, in centimeters. | 5 minutes | |
Secondary | Blood Pressure | measurement blood pressure (mmHg) through digital tensiometer OMRON. | 15 minutes | |
Secondary | 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). | 20 minutes | |
Secondary | 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). | 20 minutes | |
Secondary | 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. | 20 minutes | |
Secondary | Fasting blood glucose | Continuous numeric variable expressed in mg/dL. | 5 minutes | |
Secondary | C-reactive protein | Continuous numeric variable expressed in mg/dL. | 5 minutes | |
Secondary | Total cholesterol | Continuous numeric variable expressed in mg/dL. | 5 minutes | |
Secondary | High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol | Continuous numeric variable expressed in mg/dL. | 5 minutes | |
Secondary | Triglycerides | Continuous numeric variable expressed in mg/dL. | 5 minutes | |
Secondary | Glycated hemoglobin A1c | Continuous numeric variable expressed in percentage (%). | 5 minutes | |
Secondary | Low density lipoprotein (LDL) cholesterol | Continuous numeric variable obtained by the Friedewald formula= Cholesterol Total - (High Density Lipoprotein + Triglyderides/5), expressed in mg/dL. | 5 minutes | |
Secondary | Quality of life assessment | application of validated questionnaire | 20 minutes | |
Secondary | Food consumption | application of validated questionnaire | 20 minutes |
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