NCT06632249 Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD
| NCT ID | NCT06632249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Attention Deficit Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2024-09-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Luis Augusto Rohde, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT06632249 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Attention Deficit Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06632249 currently recruiting?
Yes, NCT06632249 is actively recruiting participants. Contact the research team at larohde@hcpa.edu.br for enrollment information.
Where is the NCT06632249 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil, Indaiatuba, Brazil.
Who is sponsoring the NCT06632249 clinical trial?
NCT06632249 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Luis Augusto Rohde, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 98 participants.