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

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

NCT Number	NCT06632249
Lead Sponsor	Hospital de Clinicas de Porto Alegre Collaborators: University of Sao Paulo, Centro de Inovação em Saúde Mental (CISM), Fundação de Amparo à Pesquisa do Estado de São Paulo, Grupo UniEDUK
Conditions	Attention Deficit Hyperactivity Disorder
Enrollment	98 participants
Start Date	2024-09-13
Primary Completion	2026-07 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2024-10-09