Virtual reality exercise game for improving attention in adolescents with ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Clinicas de Porto Alegre
• Study coordinator: Luis Augusto Rohde, PhD
• Email: larohde@hcpa.edu.br
• Phone: +55 51 33598094

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.