Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
NCT06632249

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

Led by Hospital de Clinicas de Porto Alegre · Updated on 2024-10-09

98

Participants Needed

2

Research Sites

111 weeks

Total Duration

On this page

Sponsors

H

Hospital de Clinicas de Porto Alegre

Lead Sponsor

U

University of Sao Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants diagnosed with ADHD according to DSM-5
  • Age between 12 and 17 years
  • No use of ADHD medication currently or for at least one month prior to enrollment
Not Eligible

You will not qualify if you...

  • Severe psychiatric or physical conditions or history of seizures preventing HIIT in VR
  • Inattention score below 12 on the SNAP-IV inattention subscale
  • IQ below 70
  • Regular intense physical activity more than twice a week
  • MRI-specific exclusions: incompatible implants or metal fragments, severe claustrophobia, respiratory difficulties, inability to remain still due to hyperactivity, body size or weight exceeding device limits, excessive involuntary movement, anatomical abnormalities

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90035-007

Actively Recruiting

2

UniEDUK-UniMax

Indaiatuba, São Paulo, Brazil, 13343-000

Not Yet Recruiting

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Research Team

L

Luis Augusto Rohde, PhD

CONTACT

P

Pietro Merola, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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