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RECRUITINGINTERVENTIONAL

Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD

Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD: A Randomized Clinical Trial With 'Move Sapiens®'

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to learn if the "Move Sapiens" exergame in Virtual Reality (VR), incorporated with a short model of High-Intensity Interval Training (HIIT), works as an intervention tool for adolescents with Attention-Deficit Hyperactivity/Disorder (ADHD). It will also assess the safety and effectiveness of this intervention. The main questions it aims to answer are: Does interacting with HIIT "Move Sapiens®" in VR improve attention and executive function in adolescents with ADHD? Does this intervention reduce other symptoms such as sleep problems and anxiety? Researchers will compare the HIIT VR exergame to a control condition. Participants will: Engage with "Move Sapiens®" in VR (intervention group) or participate in a control condition with an adapted version of the exergame without physical exercise (control group) (five times a week for 4 weeks). Visit the clinic for assessments and tests. The analysis will involve comparing group means using a mixed model and calculating effect sizes with Cohen's d to determine the clinical relevance of the results

Who May Be Eligible (Plain English)

Who May Qualify: - participants with diagnosis of ADHD according to DSM-5; - age between 12 and 17 years; - no prior use of ADHD medication or have not been using ADHD medication for at least one month. Who Should NOT Join This Trial: - participants with conditions and comorbidities that prevent the execution of HIIT in VR, such as severe additional psychiatric and physical conditions and a history of seizures; - inattention score below 12 on the SNAP-IV inattention subscale; - IQ below 70; - recreationally active people who engage in intense, systematic physical activity more than two times a week. For the MRI assessment, the following exclusionary criteria are added: - participants with non-compatible aneurysm clips, cochlear implants, pacemakers, metal fragments in the body or eyes, or non-removable piercings; - internal metal residues that interfere with image acquisition and analysis; - severe claustrophobia; - respiratory difficulties that prevent cooperation; - inability to remain still due to hyperactivity; - body weight and size exceeding device limits; - excessive involuntary movement; - anatomical abnormalities. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * participants with diagnosis of ADHD according to DSM-5; * age between 12 and 17 years; * no prior use of ADHD medication or have not been using ADHD medication for at least one month. Exclusion Criteria: * participants with conditions and comorbidities that prevent the execution of HIIT in VR, such as severe additional psychiatric and physical conditions and a history of seizures; * inattention score below 12 on the SNAP-IV inattention subscale; * IQ below 70; * recreationally active people who engage in intense, systematic physical activity more than two times a week. For the MRI assessment, the following exclusionary criteria are added: * participants with non-compatible aneurysm clips, cochlear implants, pacemakers, metal fragments in the body or eyes, or non-removable piercings; * internal metal residues that interfere with image acquisition and analysis; * severe claustrophobia; * respiratory difficulties that prevent cooperation; * inability to remain still due to hyperactivity; * body weight and size exceeding device limits; * excessive involuntary movement; * anatomical abnormalities.

Treatments Being Tested

OTHER

Practice with the virtual reality game

4 weeks of practice with the virtual reality game, totalling 20 sessions, 5 supervised in the laboratory and 15 at home with remote monitoring.

Locations (2)

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
UniEDUK-UniMax
Indaiatuba, São Paulo, Brazil