High-Intensity VR Exergaming for Adolescents With ADHD: A Randomized Clinical Trial Protocol (Preprint)

BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental condition affecting approximately 7–8% of children and adolescents, characterized by persistent inattention, hyperactivity, and impulsivity. Adolescence represents a period of heightened vulnerability, during which pharmacological treatments are frequently limited by adverse effects, suboptimal adherence, and partial response. Physical exercise, particularly high-intensity interval training (HIIT), has demonstrated superior effects on inhibitory control and inattention compared with moderate-intensity continuous exercise. However, the repetitive nature and high perceived exertion of traditional HIIT protocols result in poor adherence, especially in individuals with ADHD. Virtual reality (VR)–based exergames have been proposed as a strategy to sustain vigorous physiological demands while maintaining intrinsic motivation. Despite this potential, the existing literature is predominantly limited by passive control conditions, which prevent the isolation of physiological effects from those attributable to VR immersion and cognitive engagement. OBJECTIVE This paper presents the protocol of a randomized clinical trial designed to evaluate whether a HIIT-based VR exergame produces greater improvements in inhibitory control and inattention symptoms compared with an active, non-exercise VR control condition in adolescents with ADHD. METHODS This multisite, parallel-group, single-blind randomized clinical trial will recruit 98 adolescents aged 12–17 years with a confirmed diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), from two outpatient centers in Brazil. Participants will be allocated 1:1 to a HIIT-based VR exergame intervention (Move Sapiens®) or to an active control condition using the same VR platform without vigorous physical exertion. The intervention comprises 20 sessions over four weeks, delivered in a home-based format following supervised laboratory familiarization. Primary outcomes are SNAP-IV inattention subscale scores and Go/No-Go commission errors. Secondary outcomes include working memory, cognitive flexibility, processing speed, impulsivity, sleep quality, and anxiety symptoms. Analyses will follow an intention-to-treat approach using linear mixed-effects models. RESULTS The trial is currently ongoing. Recruitment commenced in June 2024 and data collection is expected to be completed by October 2026, with results anticipated shortly thereafter. CONCLUSIONS This trial will provide controlled evidence on the efficacy of a HIIT-based VR exergame for adolescents with ADHD, using an active control condition matched for technological immersion. The design will enable determination of whether elevated metabolic load constitutes an essential active component for improvements in inhibitory control and inattention in this population. If effective, the intervention may offer an engaging, home-based adjunctive treatment option for adolescents with ADHD. CLINICALTRIAL ClinicalTrials.gov - NCT06632249