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Studies

Interventional Recruiting

NCT06632249 on ClinicalTrials.gov

Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD

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

  • Sponsor: Hospital de Clínicas de Porto Alegre
  • Collaborators: University of Sao Paulo, Centro de Inovação em Saúde Mental (CISM), Fundação de Amparo à Pesquisa do Estado de São Paulo, Grupo UniEDUK
  • Enrollment: 98 (Estimated)
  • Study start: 2024-09-13 (Actual)
  • Primary completion: 2026-07-01 (Estimated)
  • Study completion: 2026-11-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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

Conditions

  • Attention Deficit Hyperactivity Disorder

Intervention / Treatment

  • Other: Practice with the virtual reality game

Primary Outcome Measures

  • Inattention total score (Pre intervention (baseline) and post intervention (4th week))
    SNAP-IV will be used to assess inattention scores. Responses to 9 items aligned with DSM-5 Inatention criteria will be collected from parents using a 4-point Likert scale.
  • Inhibibitory Control (Pre intervention (baseline) and post intervention (4th week))
    Inhibitory control will be assessed with a computerized Go/No Go task. Number of Comission Errors corrected by age will be the outcome used.

Countries

Brazil

Locations and Investigators

  • Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (Recruiting)
    • Luis Augusto Rohde, PhD
    • Pietro Merola, PhD
  • UniEDUK-UniMax, Indaiatuba, Brazil (Not yet recruiting)
    • Euripedes C Miguel, PhD
    • Luana FO Saunders, PhD

Study Officials