Attention Deficit Hyperactivity DisorderVRADHDNCT06632249
Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD
A study testing Practice with the virtual reality game in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Practice with the virtual reality game
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 2 sitesBrazil
- Study dates
- 13 Sep 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
UniEDUK-UniMax
Indaiatuba, São Paulo, 13343-000
Euripedes C Miguel, PhD, +55 11 26610000, ecmiguel7@gmail.com
Luana FO Saunders, PhD, +55 19 38947802, luanaindaia@yahoo.com.br
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
Luis Augusto Rohde, PhD, +55 51 33598094, larohde@hcpa.edu.br
Pietro Merola, PhD, +55 51 33598094, pietrokmerola@gmail.com
About this study
Official title: Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD: A Randomized Clinical Trial With 'Move Sapiens®'
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
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, affecting 3-5% of the global school-age population. Literature data show that high-intensity interval training (HIIT) is a potential intervention for ADHD inattentive symptoms and cognitive functioning deficits. These neuromodulatory effects have great potential to enhance neural plasticity and improve the executive functions of patients with ADHD. Furthermore, virtual reality (VR) can increase motivation for general activities, being a possible interesting tool, especially for people with ADHD.
Therefore, this study will investigate the potential of the 'Move Sapiens®' exergame in VR as an intervention tool for adolescents with ADHD. The primary objective is to assess whether interacting with 'Move Sapiens®' in VR can induce observable improvements in executive function and attention, a secondary objective is investigating a possible reduction in symptoms such as sleep problems and anxiety. Data will be obtained through validated questionnaires, in evaluation sessions conducted by clinicians and neuropsychologist, before and after the intervention. Ninety-eight participants, aged 12 to 17 with ADHD, will be randomly allocated in two groups that will interact with two versions of the VR 'Move Sapiens®' (with and without HIIT) during 20 sessions over 4 weeks. The four initial sessions and the last session will be performed in the laboratory. In these sessions, heart hate will also be monitored. Other sessions will be done at home with remote supervision. In all sessions, the game score will be monitored. The experimental group will practice the exergame, which incorporates a short model of HIIT, consisting of 12 cycles that include 16 seconds of maximum effort followed by 20 seconds of rest (total: 7 minutes and 12 seconds). In the control group, participants will engage in an adapted version of the Move Sapiens exergame without physical exercise, interacting through the joystick. This randomized clinical trial will be conducted in two centres: the Hospital de Clínicas de Porto Alegre (HCPA), and the Centro de Escola de Especialidades Médicas (CEEM - UniEduk/UniMax).
Furthermore, in a small convenience subsample of 30 participants (15 intervention and 15 control group) from the Porto Alegre-RS, we will explore a possible biological mechanism ("brain signature") associated with improved attention, detectable by fMRI, suggesting potential changes in brain function detectable through neuroimaging.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Practice with the virtual reality game
- Keywords
- Virtual Reality (VR), High-Intensity Interval Training (HIIT)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice with the virtual reality gameOther
Also called Move Sapiens®
4 weeks of practice with the virtual reality game, totalling 20 sessions, 5 supervised in the laboratory and 15 at home with remote monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Practice with the virtual reality game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre intervention (baseline) and post intervention (4th week)
Secondary outcomes (7)
Verbal Working Memory
The Digit Symbol Test evaluates verbal working memory and the outcome will be the scaled score for the backward condition.
Measured: Pre intervention (baseline) and post intervention (4th week)
Spatial Working Memory
The Spatial Span Task is designed based on the Corsi Block, it evaluates spatial working memory. The outcome is the number of correct responses corrected by age for the backward condition
Measured: Pre intervention (baseline) and post intervention (4th week)
Cognitive Flexibility
Trail Making Test will be used to evaluate cognitive flexibility. The outcome will be the time to complete B form corrected by age.
Measured: Pre intervention (baseline) and post intervention (4th week)
Reaction Time
The Two-Choice Reaction Time task assesses processing speed and the score used will be the average reaction time corrected by age.
Measured: Pre intervention (baseline) and post intervention (4th week)
Sleep quality
To assess sleep quality, we will use the Pittsburgh Sleep Quality Index (PSQI). This instrument is a self-administered questionnaire that investigates sleep quality over a one-month interval. The PSQI focuses on seven components: sleep latency, duration, efficiency, disturbances, use of sleep medication, daytime dysfunction, and subjective sleep quality. A higher total score on the PSQI indicates poorer sleep quality.
Measured: Pre intervention (baseline) and post intervention (4th week)
Anxiety symptoms
To assess anxiety symptoms, we will use the 7-item Generalized Anxiety Disorder Scale (GAD-7). Participants will report the frequency of their anxiety symptoms over the past two weeks using a 4-point Likert scale, aiding in identifying and assessing the severity of generalized anxiety disorder.
Measured: Pre intervention (baseline) and post intervention (4th week)
Impulsivity and attention
The MOXO-continuous performance test measures four domains, including attention, timeliness, hyperactivity and impulsivity. We will use the Impulsivity z-score to assess impulsivity.
Measured: Pre intervention (baseline) and post intervention (4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start13 Sep 2024
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Centro de Inovação em Saúde Mental (CISM), Fundação de Amparo à Pesquisa do Estado de São Paulo, Grupo UniEDUK
- Responsible party
- Sponsor
- Investigators
- Luis Augusto Rohde, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632249
- Sponsor's protocol ID
- 2023-0540
- Acronym
- VRADHD
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Romero Meller M, Balbinot Zanini N, Keitel Machado R, Wagner F, Bolzan G, Farias Oliveira Saunders L, Carvalho Chagas M, Rohde LA, Merola P. High-Intensity Virtual Reality Exergaming for Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 Jul 14;15:e94797. doi: 10.2196/94797.
PubMed 42446902
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD: A Randomized Clinical Trial With 'Move Sapiens®'
- ClinicalTrials.gov ID
- NCT06632249
- Acronym / sponsor ID
- VRADHD / 2023-0540
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Virtual Reality (VR), High-Intensity Interval Training (HIIT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Centro de Inovação em Saúde Mental (CISM), Fundação de Amparo à Pesquisa do Estado de São Paulo, Grupo UniEDUK
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, affecting 3-5% of the global school-age population. Literature data show that high-intensity interval training (HIIT) is a potential intervention for ADHD inattentive symptoms and cognitive functioning deficits. These neuromodulatory effects have great potential to enhance neural plasticity and improve the executive functions of patients with ADHD. Furthermore, virtual reality (VR) can increase motivation for general activities, being a possible interesting tool, especially for people with ADHD.
Therefore, this study will investigate the potential of the 'Move Sapiens®' exergame in VR as an intervention tool for adolescents with ADHD. The primary objective is to assess whether interacting with 'Move Sapiens®' in VR can induce observable improvements in executive function and attention, a secondary objective is investigating a possible reduction in symptoms such as sleep problems and anxiety. Data will be obtained through validated questionnaires, in evaluation sessions conducted by clinicians and neuropsychologist, before and after the intervention. Ninety-eight participants, aged 12 to 17 with ADHD, will be randomly allocated in two groups that will interact with two versions of the VR 'Move Sapiens®' (with and without HIIT) during 20 sessions over 4 weeks. The four initial sessions and the last session will be performed in the laboratory. In these sessions, heart hate will also be monitored. Other sessions will be done at home with remote supervision. In all sessions, the game score will be monitored. The experimental group will practice the exergame, which incorporates a short model of HIIT, consisting of 12 cycles that include 16 seconds of maximum effort followed by 20 seconds of rest (total: 7 minutes and 12 seconds). In the control group, participants will engage in an adapted version of the Move Sapiens exergame without physical exercise, interacting through the joystick. This randomized clinical trial will be conducted in two centres: the Hospital de Clínicas de Porto Alegre (HCPA), and the Centro de Escola de Especialidades Médicas (CEEM - UniEduk/UniMax).
Furthermore, in a small convenience subsample of 30 participants (15 intervention and 15 control group) from the Porto Alegre-RS, we will explore a possible biological mechanism ("brain signature") associated with improved attention, detectable by fMRI, suggesting potential changes in brain function detectable through neuroimaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT VR | Experimental | Other: Practice with the virtual reality gameThe 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. |
| Sedentary VR | Sham comparator | Other: Practice with the virtual reality gameParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice with the virtual reality gameAlso: Move Sapiens®4 weeks of practice with the virtual reality game, totalling 20 sessions, 5 supervised in the laboratory and 15 at home with remote monitoring. | Other | HIIT VR, Sedentary VR |
Primary outcome
Inattention total score
Time frame: 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
Time frame: 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.
7 secondary outcomes
Verbal Working Memory
Time frame: Pre intervention (baseline) and post intervention (4th week)
Spatial Working Memory
Time frame: Pre intervention (baseline) and post intervention (4th week)
Cognitive Flexibility
Time frame: Pre intervention (baseline) and post intervention (4th week)
Reaction Time
Time frame: Pre intervention (baseline) and post intervention (4th week)
Sleep quality
Time frame: Pre intervention (baseline) and post intervention (4th week)
Anxiety symptoms
Time frame: Pre intervention (baseline) and post intervention (4th week)
Impulsivity and attention
Time frame: Pre intervention (baseline) and post intervention (4th week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 42446902Romero Meller M, Balbinot Zanini N, Keitel Machado R, Wagner F, Bolzan G, Farias Oliveira Saunders L, Carvalho Chagas M, Rohde LA, Merola P. High-Intensity Virtual Reality Exergaming for Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 Jul 14;15:e94797. doi: 10.2196/94797.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis Augusto Rohde, PhD principal investigator
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice with the virtual reality game in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Augusto Rohde, PhD (+55 51 33598094, larohde@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inattention total score (time frame: Pre intervention (baseline) and post intervention (4th week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06632249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.