Physical InactivityNCT06646874
Active Video Game Influence Cognitive Ability
A study testing VR game in people with Physical Inactivity, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The experiment was conducted at the Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University between February 2024 and May 2024. During the briefing, all questions were answered to ensure that participants understood the experiment and its objectives. Read more about this study
- Who is it for?
- Ages 18 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- VR game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 23 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female college students
- Low physical activity (inactive)
- Age (18 to 23 years)
- No previous medical condition affecting PA level
- No visual impairments
- Have never experienced the VR game used in the trial
Who cannot join
- Male students
- Physically active
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University
Al Kharj, Central, 11942
About this study
Official title: Active Video Game Using Virtual Reality Influence Cognitive Ability in Sedentary Female University Students: Randomized Clinical Trial
The experiment was conducted at the Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University between February 2024 and May 2024. During the briefing, all questions were answered to ensure that participants understood the experiment and its objectives. On the day of the experiment, demographic information was collected, including age, height, weight, body mass index (BMI), and preferred leg. An Eye-Level Weight Beam scale (Detecto, Webb City, MO, USA) was used to determine the weight and height of the subjects. To identify the preferred leg, participants were observed ascending stairs or kicking a ball.
Participants were recruited and assigned to one of two groups, either the control group or the VR group. Participants were required to attend one experimental session in a random order using Microsoft Excel's (Microsoft Corp., Redmond, WA, USA) random list function. The VR group was required to play a 20-minute game of Beat Saber VR, while the control group was asked to sit quietly for 20 minutes without any activities assigned. This study used an accelerometer from ActivPal (PAL Technologies Ltd, Glasgow, UK) to capture the PA levels of the VR group throughout the VR game. Following previously published validation studies and manufacturer recommendations, a strip of Tegaderm (3M, St. Paul, MN) was attached to the preferred leg's front thigh.
- Conditions
- Physical Inactivity
- Being tested
- VR game
- Keywords
- Virtual Reality, Cognitive performance, Physical activity, Sedentary female student
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR gameBehavioural
Each participant in the VR group completed a five-minute familiarization session with the VR game before the experimental session. Following the familiarization session, participants in the VR group were instructed to complete the Montreal Cognitive Assessment (MoCA) Arabic version (pre-test: Arabic version 8.1 and post-test: Arabic version 8.2)
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group completed the MoCA pre- and post-tests 20 minutes apart. A debriefing was conducted for the participants following the conclusion of the experiment. |
| VR group | Experimental | Each participant in the VR group completed a five-minute familiarization session with the VR game before the experimental session. Following the familiarization session, participants in the VR group were instructed to complete the Montreal Cognitive Assessment (MoCA) Arabic version (pre-test: Arabic version 8.1 and post-test: Arabic version 8.2) Receives: Behavioral: VR game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
Developed as a screening instrument to detect mild cognitive impairment, the Montreal Cognitive Assessment (MoCA) uses a series of questions to assess cognitive impairment. A paper-and-pencil assessment is administered and scored out of 30 points. In addition to attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation, and orientation, the MoCA assesses several cognitive domains. There are 56 languages and dialects translation of the MoCA and it is widely used throughout the world
Measured: 20 minutes
ActivPal
The ActivPAL is a posture and activity tracker that uses a tri-axial accelerometer to measure movement and activity. The device collects information such as bouts of sitting, lying, standing, and stepping, and allows data to be retrieved by week, day, or hour. As a valid and reliable tool to detect PA, ActivPal can be used in a variety of populations and settings (64). From the ActivPal, the following variables were collected for each participant in the VR group: total MET, total number of steps, total time stepping, number of sit-to-stands, and number of stands-to-sit.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646874
- Sponsor's protocol ID
- RHPT/023/007
- Status last verified
- Oct 2024
- First submitted
- 19 Aug 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video Game Using Virtual Reality Influence Cognitive Ability in Sedentary Female University Students: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06646874
- Acronym / sponsor ID
- RHPT/023/007
- Conditions
- Physical Inactivity
- Keywords
- Virtual Reality, Cognitive performance, Physical activity, Sedentary female student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 17 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 experiment was conducted at the Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University between February 2024 and May 2024. During the briefing, all questions were answered to ensure that participants understood the experiment and its objectives. On the day of the experiment, demographic information was collected, including age, height, weight, body mass index (BMI), and preferred leg. An Eye-Level Weight Beam scale (Detecto, Webb City, MO, USA) was used to determine the weight and height of the subjects. To identify the preferred leg, participants were observed ascending stairs or kicking a ball.
Participants were recruited and assigned to one of two groups, either the control group or the VR group. Participants were required to attend one experimental session in a random order using Microsoft Excel's (Microsoft Corp., Redmond, WA, USA) random list function. The VR group was required to play a 20-minute game of Beat Saber VR, while the control group was asked to sit quietly for 20 minutes without any activities assigned. This study used an accelerometer from ActivPal (PAL Technologies Ltd, Glasgow, UK) to capture the PA levels of the VR group throughout the VR game. Following previously published validation studies and manufacturer recommendations, a strip of Tegaderm (3M, St. Paul, MN) was attached to the preferred leg's front thigh.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group completed the MoCA pre- and post-tests 20 minutes apart. A debriefing was conducted for the participants following the conclusion of the experiment. |
| VR group | Experimental | Behavioral: VR gameEach participant in the VR group completed a five-minute familiarization session with the VR game before the experimental session. Following the familiarization session, participants in the VR group were instructed to complete the Montreal Cognitive Assessment (MoCA) Arabic version (pre-test: Arabic version 8.1 and post-test: Arabic version 8.2) |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female college students
- Low physical activity (inactive)
- Age (18 to 23 years)
- No previous medical condition affecting PA level
- No visual impairments
Key exclusion criteria (2 listed)
- Male students
- Physically active
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 |
|---|---|---|
| VR gameEach participant in the VR group completed a five-minute familiarization session with the VR game before the experimental session. Following the familiarization session, participants in the VR group were instructed to complete the Montreal Cognitive Assessment (MoCA) Arabic version (pre-test: Arabic version 8.1 and post-test: Arabic version 8.2) | Behavioural | VR group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 20 minutes
Developed as a screening instrument to detect mild cognitive impairment, the Montreal Cognitive Assessment (MoCA) uses a series of questions to assess cognitive impairment. A paper-and-pencil assessment is administered and scored out of 30 points. In addition to attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation, and orientation, the MoCA assesses several cognitive domains. There are 56 languages and dialects translation of the MoCA and it is widely used throughout the world
ActivPal
Time frame: 20 minutes
The ActivPAL is a posture and activity tracker that uses a tri-axial accelerometer to measure movement and activity. The device collects information such as bouts of sitting, lying, standing, and stepping, and allows data to be retrieved by week, day, or hour. As a valid and reliable tool to detect PA, ActivPal can be used in a variety of populations and settings (64). From the ActivPal, the following variables were collected for each participant in the VR group: total MET, total number of steps, total time stepping, number of sit-to-stands, and number of stands-to-sit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR game in people with Physical Inactivity, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 17 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 1 site in Saudi Arabia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 20 minutes). 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?
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 17 Oct 2024.