At-home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Body mass index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The trial will be conducted in a single-blinded structure, ensuring that all the participants are blinded to treatment or control related information. The experiment coordinators are unblinded and responsible for labelling the groups, allocating experimental equipment and materials, gathering data from participants and clinics, and analyzing all the relationships between and within the two groups.
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Body mass index
时间窗: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Weight and height will be combined to report body mass index in kg/m\^2.
High-density lipoprotein cholesterol (HDL-C)
时间窗: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
HDL-C concentration less than 35 mg/dl for men (39 mg/dl for women).
Low-density lipoprotein cholesterol (LDL-C)
时间窗: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
LDL-C \< 160 mg/dl
Triglycerides
时间窗: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Triglycerides concentration \> 150 mg/dl.
Hypertension
时间窗: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
a Systolic blood pressure \> 140 mmHg AND diastolic blood pressure \< 90 mmHg.
Impaired fasting glucose
时间窗: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
a fasting plasma glucose (FPG) concentration between 6.1 and 6.9 mmol/l.
次要结局
- Exercise time (including exergaming time)(Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).)
- Sedentary time(Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).)
研究者
Zhao Jing
Associate Researcher
Guangzhou University
