Clinical trial NCT06556784: Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health
Official title: At-home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exergaming
Metabolic Syndrome
Keywords: Immersive virtual reality
Physical activity
Office workers
Lead sponsor: Guangzhou University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
measure: Impaired fasting glucose
timeFrame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
measure: Triglycerides
timeFrame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
measure: Hypertension
timeFrame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
measure: Body mass index
timeFrame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Secondary outcomes:
measure: Exercise time (including exergaming time)
timeFrame: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).
measure: Sedentary time
timeFrame: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).
Other outcomes:
Locations:
Study officials:
References: