Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000761561p
Ethics application status
Not yet submitted
Date submitted
7/05/2024
Date registered
21/06/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
21/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Exercise, Real Effects: Impact of moderate/high intensity exercise with inmersive virtual reality on cognition, cardiovascular fitness and satisfaction in adolescents.
Scientific title
Cognitive, cardiovascular and psychological effects of virtual reality use during moderate/high intensity physical exercise in adolescents.
Secondary ID [1] 312048 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular fitness 333658 0
Cognitive dysfunction 333659 0
Condition category
Condition code
Cardiovascular 330344 330344 0 0
Normal development and function of the cardiovascular system
Mental Health 330346 330346 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive, cardiovascular and psychological effects of the use of virtual reality during moderate/high intensity physical exercise in adolescents.

The present research project aims to introduce virtual reality exercise as an alternative to traditional approaches, and thus learn about the effects it induces on cognition and other health variables mentioned above, in order to promote its use and implementation in daily life.

Meta Quest 2 virtual reality headset will be used by the experimental group of the research. They will play two virtual games, "The Thrill of the fight" and "Audioshield modded". Heart rate will be monitored with a Polar RS800cx heart rate monitor to ensure that the required physical activity demand is being met.

The intervention will be performed primarily by one of the researchers, Joaquín Ordóñez Vega, a sports science graduate with a master's degree in sports physical performance. He has two and a half years of experience. Dr. Borja Sañudo Corrales, in his role as principal investigator of the research project, will assume responsibility for the training plan and supervise the whole process. He is a professor in sports science. He has an extensive background in initiatives addressing the impact of exercise and other aspects of lifestyle in driving improvements in physiological function, quality of life and prolonging disease-free health in clinical groups.

The intervention will be conducted for 12 weeks and with a frequency of 2 workouts per week. The duration of the training sessions will be 30 minutes. It will be carried out face-to-face in a secondary school, from October 2024 to June 2025.

Participants would be required to be in the range of 60-80% of max. heart rate while completing game objectives, doing aerobic exercise while boxing (The Thrill of the Fight), and "blocking spheres" to the rhythm of music (Audioshield modded). The level of intensity will be assessed using the HR monitor and Borg RPE Scale.

The exercise regime will vary depending on the effort that the game generates for each subject. As there is a lot of variation in how each person plays, we will modify the intensity of the game using the different levels of difficulty, thus adjusting to the 60-80% intensity required for each subject.

An attendance checklist will be used to monitor and ensure attendance.
Intervention code [1] 328493 0
Lifestyle
Intervention code [2] 328494 0
Treatment: Devices
Comparator / control treatment
The control group is an active control group that will perform the same training protocol as the experimental group, 2 workouts/week of 30 minutes for 12 weeks, face-to-face consultation. The control group, unlike the experimental group, will perform the protocol without using virtual reality.

Subjects will attend group sessions. These group sessions will have a maximum of 6 participants, with supervision and monitoring by at least one researcher.

Each game has a metabolic equivalent, rated by the VR Health Institute. In the case of the Thrill of the Fight is rowing (https://vrhealth.institute/portfolio/thrill-of-the-fight/) and biking in the case of Audioshield modded (https://vrhealth.institute/portfolio/audioshield-modded/). Subjects will perform the respective activity at the specified intensity (60-80% MaxHR).

As well the experimental group, an attendance checklist will be used to monitor and ensure attendance.
Control group
Active

Outcomes
Primary outcome [1] 338120 0
Any change in selective attention.
Timepoint [1] 338120 0
Baseline and one week post-completion of the final exercise session. (13 weeks post-baseline)
Primary outcome [2] 338440 0
Any change in cognitive flexibility.
Timepoint [2] 338440 0
Baseline and 13 weeks after the start of the intervention
Secondary outcome [1] 434594 0
[Primary outcome] Any change in cardiovascular fitness
Timepoint [1] 434594 0
Baseline and one week post-completion of the final exercise session. (13 weeks post-baseline)
Secondary outcome [2] 434595 0
[Primary outcome] Any change in participant satisfaction
Timepoint [2] 434595 0
Baseline and one week post-completion of the final exercise session. (13 weeks post-baseline)

Eligibility
Key inclusion criteria
Healthy males and females between 12 and 17 years old.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of metabolic, neurological, cognitive, cardiovascular pathologies or musculoskeletal injuries

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Student's t test for paired samples and student's t test for independent samples

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
27/09/2024
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 26288 0
Spain
State/province [1] 26288 0
Sevilla

Funding & Sponsors
Funding source category [1] 316457 0
University
Name [1] 316457 0
Universidad de Sevilla
Country [1] 316457 0
Spain
Primary sponsor type
University
Name
Universidad de Sevilla
Address
Country
Spain
Secondary sponsor category [1] 318631 0
None
Name [1] 318631 0
None
Address [1] 318631 0
Country [1] 318631 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315205 0
Comité de Ética de la Investigación de la Universidad de Sevilla
Ethics committee address [1] 315205 0
CRAI-Antonio de Ulloa, Avda. Reina Mercedes; s/n, 4ª planta, Seminario 1. 41012-Sevilla
Ethics committee country [1] 315205 0
Spain
Date submitted for ethics approval [1] 315205 0
28/06/2024
Approval date [1] 315205 0
Ethics approval number [1] 315205 0

Summary
Brief summary
The purpose of this research project is to introduce virtual reality exercise to healthy adolescents for 12 weeks as an alternative to traditional approaches, and to learn about the effects it induces on cognition, cardiovascular condition and exercise satisfaction, in order to promote its use and implementation in daily life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133974 0
Dr Francisco de Borja Sañudo Corrales
Address 133974 0
Departamento de Educación Física y Deporte, C. Pirotecnia, s/n, 41013 Sevilla, España
Country 133974 0
Spain
Phone 133974 0
+34652387090
Fax 133974 0
Email 133974 0
bsancor@us.es
Contact person for public queries
Name 133975 0
Joaquín Ordóñez Vega
Address 133975 0
Departamento de Educación Física y Deporte, C. Pirotecnia, s/n, 41013 Sevilla, España
Country 133975 0
Spain
Phone 133975 0
+34 622 02 75 06
Fax 133975 0
Email 133975 0
joaquinordonezvega@gmail.com
Contact person for scientific queries
Name 133976 0
Joaquín Ordóñez Vega
Address 133976 0
Departamento de Educación Física y Deporte, C. Pirotecnia, s/n, 41013 Sevilla, España
Country 133976 0
Spain
Phone 133976 0
+34 622 02 75 06
Fax 133976 0
Email 133976 0
joaquinordonezvega@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.