High-Intensity Virtual Reality Exergaming for Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Clinical Trial.

backgroundAttention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental condition affecting approximately 7% to 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 adequate control for the effects of VR immersion and cognitive engagement, limiting causal inference regarding the specific contribution of physiological exertion.

objectiveThis paper presents the protocol for a randomized clinical trial designed to evaluate whether an HIIT-based VR exergame produces greater improvements in inhibitory control and inattention symptoms compared with an active, nonexercise VR control condition in adolescents with ADHD.

methodsThis multisite, parallel-group, single-blind randomized clinical trial will recruit 98 adolescents aged 12 to 17 years with a confirmed diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, from 2 outpatient centers in Brazil. Participants will be allocated 1:1 to an HIIT-based VR exergame intervention (Move Sapiens) or an active control condition using the same VR platform without vigorous physical exertion. The intervention comprises 20 sessions over 4 weeks delivered in a home-based format following supervised laboratory familiarization. Primary outcomes are Swanson, Nolan, and Pelham Rating Scale version 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.

resultsThe trial is ongoing. Funding was granted in October 2024. As of April 2026, 58 participants have been enrolled across 2 sites, of whom 46 (79.3%) have completed the full intervention protocol. Data collection is expected to be completed by October 2026, with results anticipated by December 2026.

conclusionsThis trial will provide controlled evidence on the efficacy of an HIIT-based VR exergame for adolescents with ADHD using an active control condition matched for technological immersion. The design will enable examination of whether vigorous physical exertion beyond VR immersion and digital engagement 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.

trial registrationClinicalTrials.gov NCT06632249; https://clinicaltrials.gov/study/NCT06632249. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/94797.