Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health

At-home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial

The worldwide increasing of prevalence of non-communicable diseases has grown the recognition of necessity for identifying the modifiable risk in preventing and managing these diseases. While, the office worker, as a representative group of physical inactivity, is exposed to risk factor of metabolic syndrome which is considered as the pathway of non-communicable diseases. This study mainly focuses on the purpose of examining the interventional efficacy of at-home immersive virtual reality exergame on several metabolic syndrome biomarkers among office workers. In addition, it purposes to determine the impacts of at-home immersive virtual reality exergame on lifestyle pattern of office workers. A 2-armed, single blinded randomized controlled trial (RCT) will be applied to examine the therapeutic effects of at-home immersive virtual reality exergame in this exploratory study. 120 Japanese office workers with less than 150 minutes per week of moderate to vigorous sports activities will be recruited by a convenience sample method. They are randomly allocated to two parallel groups, which including an intervention group: 12-week training of at least 150 minutes per week at-home immersive virtual reality exergame playing with a set device of Meta Quest 2, a control group: 12-week of maintaining regular exercise, eating, and working habits without making significant changes. During this 12-week trial, 3 main follow up steps are included at the timelines of 0 week, 6 weeks, 12 weeks. For each follow up, we will collect three types of variables, including major clinical risk factors of metabolic syndrome, lifestyle pattern factors of metabolic syndrome, and demographics (0 week only). To analysis the variance between intervention group and control group, mixed linear model will be applied to understand the efficacy result of this intervention. The variances of metabolic syndrome clinical risk factors between groups would be used to express the therapeutic effects of at-home immersive virtual reality exergame. The changes of lifestyle pattern factors would be applied to show the impacts of at-home immersive virtual reality exergame on lifestyle pattern.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; Exergaming
• Intervention / Treatment: Behavioral: 12-week at-home immersive virtual reality exergame

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Zhao, PhD; Phone Number: +86-13170322723; Email: zhaojing@gzhu.edu.cn
• Study Contact Backup: Name: Jiuling Li, Masters; Phone Number: +81-7083895217; Email: hebitoto123@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-64 years old
• Capable of standing and exercising.
• Having no history of diagnosis of heart disease, cancer, or dementia.
• Being interested in playing with the exergames.
• Willingness of adhering to a 12-week interventional exergame treatment.

Exclusion Criteria:

• Individuals who are already engaged in more than 150 minutes per week of moderate to vigorous activities.
• Individuals with some pharmacological treatments, some surgery (bariatric surgery), and some traditional Chinese medicine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-week at-home immersive virtual reality exergame; 12-week training of at least 150 minutes per week at-home immersive virtual reality exergame playing with a set device of Meta Quest 2 and maintaining regular eating and working habits without making significant changes.	Behavioral: 12-week at-home immersive virtual reality exergame; 12-week training of at least 150 minutes per week at-home immersive virtual reality exergame playing with a set device of Meta Quest 2 and maintaining regular eating and working habits without making significant changes.
No Intervention: 12-week control in awaiting; Maintaining regular eating and working habits without making significant changes throughout the 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-density lipoprotein cholesterol (HDL-C)	HDL-C concentration less than 35 mg/dl for men (39 mg/dl for women).	Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Low-density lipoprotein cholesterol (LDL-C)	LDL-C < 160 mg/dl	Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Impaired fasting glucose	a fasting plasma glucose (FPG) concentration between 6.1 and 6.9 mmol/l.	Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Triglycerides	Triglycerides concentration > 150 mg/dl.	Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Hypertension	a Systolic blood pressure > 140 mmHg AND diastolic blood pressure < 90 mmHg.	Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Body mass index	Weight and height will be combined to report body mass index in kg/m^2.	Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise time (including exergaming time)	Total minutes of exercise time and exergaming time per week.	Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).
Sedentary time	Total minutes of sedentary time per week.	Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).

Collaborators and Investigators

• Sponsor: Guangzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Office workers; Immersive virtual reality
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: VRGOWH2024Z

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No