NCT06646874

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

August 19, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

Virtual RealityCognitive performancePhysical activitySedentary female student

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    20 minutes

Study Arms (2)

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)

Behavioral: VR game

Interventions

VR gameBEHAVIORAL

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)

VR group

Eligibility Criteria

Age18 Years - 23 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Male students
  • Physically active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University

Al Kharj, Central, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were required to attend one experimental session in a random order using Microsoft Excel's (Microsoft Corp., Redmond, WA, USA) random list function.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

October 17, 2024

Study Start

January 1, 2024

Primary Completion

June 1, 2024

Study Completion

July 30, 2024

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations