Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health
NCT Number: NCT06556784
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exergaming|Metabolic Syndrome
Interventions: BEHAVIORAL: 12-week at-home immersive virtual reality exergame
Sponsor: Guangzhou University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-04
Completion Date: 2027-04

Summary:
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.

Primary Outcome Measures: 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: 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).