Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632249
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD A Randomized Clinical Trial With Move Sapiens
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRADHD
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 HyperactivityDisorder 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 Cohens d to determine the clinical relevance of the results
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 Cohens d to determine the clinical relevance of the results
Detailed Description:
Attention-DeficitHyperactivity 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 - UniEdukUniMax
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
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 - UniEdukUniMax
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None