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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
| Centro de Inovação em Saúde Mental (CISM) | UNKNOWN |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Working Memory | The Digit Symbol Test evaluates verbal working memory and the outcome will be the scaled score for the backward condition. | Pre intervention (baseline) and post intervention (4th week) |
| Spatial Working Memory |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) | In a small convenience subsample from the Porto Alegre-RS group, fifteen participants from the intervention group and fifteen participants from the control group who provide informed consent (ICF) will have functional neuroimaging collected at the Brain Institute (InsCer) of PUCRS at baseline (T0) before the intervention, and within 7 days after the interventions (T1). The image acquisition time will be 40 minutes, and both resting-state fMRI and task-based fMRI images will be collected, using attention and inhibitory control tasks. |
Inclusion Criteria:
Exclusion Criteria:
For the MRI assessment, the following exclusionary criteria are added:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Augusto Rohde, PhD | Contact | +55 51 33598094 | larohde@hcpa.edu.br | |
| Pietro Merola, PhD | Contact | +55 51 33598094 | pietrokmerola@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis Augusto Rohde, PhD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-007 | Brazil |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Grupo UniEDUK |
| UNKNOWN |
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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.
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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
| 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. | 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. | 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. | 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. | 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. | Pre intervention (baseline) and post intervention (4th week) |
| Pre intervention (baseline) and post intervention (4th week) |
| Heart Rate | Heart rate (HR) data will be used as an objective measure of exercise intensity. HR recording will be evaluated during the 5 in-person training sessions, measuring the average and maximum HR (average HR and HRmax). A heart rate monitor (Polar H10) will be used for this purpose. Heart rate recovery (HRR: Δ bpm) will be measured during 5 minutes of recovery, and the average will be calculated every 5 seconds. Heart rate variability (HRV) will also be recorded (Polar beat app) and analysed using the Kubios software, in rest state and during a cognitive task. | Pre intervention (baseline) and post intervention (4th week) |
| Participants' experiences in the game | The Game Experience Questionnaire will explore participants 'experiences related to the game, covering dimensions such as immersion, flow, and affect. | Pre intervention (baseline) and post intervention (4th week) |
| Discomfort associated with the use of virtual reality | To assess discomfort associated with the use of virtual reality in our project, we will use the Simulator Sickness Questionnaire (SSQ). The 16-item questionnaire measures the incidence and severity of motion sickness symptoms in three categories: nausea, oculomotor issues, and disorientation. | Pre intervention (baseline) and post intervention (4th week) |
| UniEDUK-UniMax | Not yet recruiting | Indaiatuba | São Paulo | 13343-000 | Brazil |
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