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

NCT06632249 | Recruiting

• 1 other identifier: 2023-0540
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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

Keywords

Virtual Reality (VR); High-Intensity Interval Training (HIIT)

Outcome Measures

Primary Outcomes (2)

• Inattention total score

  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.

  Pre intervention (baseline) and post intervention (4th week)

• Inhibibitory Control

  Inhibitory control will be assessed with a computerized Go/No Go task. Number of Comission Errors corrected by age will be the outcome used.

  Pre intervention (baseline) and post intervention (4th week)

Secondary Outcomes (7)

• Verbal Working Memory

  Pre intervention (baseline) and post intervention (4th week)

• Spatial Working Memory

  Pre intervention (baseline) and post intervention (4th week)

• Cognitive Flexibility

  Pre intervention (baseline) and post intervention (4th week)

• Reaction Time

  Pre intervention (baseline) and post intervention (4th week)

• Sleep quality

  Pre intervention (baseline) and post intervention (4th week)

Other Outcomes (4)

• Functional Magnetic Resonance Imaging (fMRI)

  Pre intervention (baseline) and post intervention (4th week)

• Heart Rate

  Pre intervention (baseline) and post intervention (4th week)

• Participants' experiences in the game

  Pre intervention (baseline) and post intervention (4th week)

Study Arms (2)

HIIT VR

EXPERIMENTAL

The virtual reality (VR) exergame 'Move Sapiens®' will be implemented through the VR headset Oculus Quest 2 (Meta®, Menlo Park, USA). The game's objective is to take as much life from the drone as possible while avoiding being hit to preserve their own life, the drone not only moves erratically but also can attack, having a defined amount of life, just like the player. Participants will use a virtual exoskeleton to interact with the environment, and their main task is to aim and punch a drone that moves unpredictably. The exergame incorporates a short HIIT model, consisting of 12 cycles that include 16 seconds of maximum effort followed by 20 seconds of rest. This structured format is intrinsic to the game's design, aiming for a balance between effort and recovery. Essential factors for the simulation design include an engaging sensory experience of enhanced physical skills and the application of powerful punches in the game design.

Other: Practice with the virtual reality game

Sedentary VR

SHAM COMPARATOR

Participants will play an adapted version of the 'Move Sapiens®' exergame in VR, which maintains the immersive environment of the original game but excludes any physical exercise component. In this version, interaction will be carried out exclusively through joystick manipulation, without requiring physical activity from the participants.

Other: Practice with the virtual reality game

Interventions

Practice with the virtual reality game OTHER

4 weeks of practice with the virtual reality game, totalling 20 sessions, 5 supervised in the laboratory and 15 at home with remote monitoring.

Also known as: Move Sapiens®

HIIT VR; Sedentary VR

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• University of Sao Paulo: collaborator
• Centro de Inovação em Saúde Mental (CISM): collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Grupo UniEDUK: collaborator

Study Sites (2)

Hospital de Clínicas de Porto Alegre

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

RECRUITING

UniEDUK-UniMax

Indaiatuba, São Paulo, 13343-000, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Luis Augusto Rohde, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Augusto Rohde, PhD

CONTACT

+55 51 33598094; larohde@hcpa.edu.br

Pietro Merola, PhD

CONTACT

+55 51 33598094; pietrokmerola@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be a single-blind clinical trial; the evaluators of the primary outcomes will be blinded, unaware of the group allocation to ensure the objectivity of the assessments. The data analysis will remain blinded to ensure that the researcher in charge is unaware of the experimental conditions, thus maintaining the impartiality of the analysis. However, the participants will be aware of their allocation group, as they will experience the different versions of the VR game 'Move Sapiens®'; one group will perform the exergame, with HIIT physical exercise, while the other will participate using a joystick, without physical exercise, which will prevent blinding of the volunteers. The training monitoring team, due to operational necessity, will also not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 9, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

BR (2)