Virtual reality exercise game for improving attention in adolescents with ADHD

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

This study is testing if a fun virtual reality exercise game can help teenagers with ADHD improve their attention and feel better overall.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Hospital de Clinicas de Porto Alegre (Academic / other)
• Locations: 2 sites (Porto Alegre, Rio Grande do Sul and 1 other locations)
• Trial ID: NCT06632249 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the 'Move Sapiens' virtual reality exergame combined with high-intensity interval training (HIIT) as an intervention for adolescents aged 12 to 17 diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). Participants will be randomly assigned to either the HIIT VR exergame group or a control group that uses a non-exercise version of the game. The study aims to assess improvements in attention and executive function, as well as reductions in symptoms like sleep problems and anxiety, through validated questionnaires and clinical evaluations. The intervention will take place over 20 sessions across four weeks, with assessments conducted before and after the program.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 12 to 17 with a diagnosis of ADHD who have not been on medication for at least one month.

Not a fit: Patients with severe psychiatric or physical conditions that prevent participation in HIIT or those who are physically active more than twice a week may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance attention and executive function in adolescents with ADHD, potentially improving their daily functioning and quality of life.

How similar studies have performed: While the combination of HIIT and VR for ADHD is a novel approach, existing literature suggests that HIIT has shown promise in improving symptoms of ADHD, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Porto Alegre, Rio Grande do Sul and 1 other locations

• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
• UniEDUK-UniMax — Indaiatuba, São Paulo, Brazil (Not_yet_recruiting)

Study contacts

• Principal investigator: Luis Augusto Rohde, PhD — Hospital de Clínicas de Porto Alegre
• Study coordinator: Luis Augusto Rohde, PhD

Conditions Attention Deficit Hyperactivity Disorder; Virtual Reality; High-Intensity Interval Training