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NCT Number: NCT06556784

Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

12-week at-home immersive virtual reality exergame

Behavioral

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.

Primary outcomes

  1. High-density lipoprotein cholesterol (HDL-C)

    Time frame: 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).

  2. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).

    LDL-C < 160 mg/dl

  3. Impaired fasting glucose

    Time frame: 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.

  4. Triglycerides

    Time frame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).

    Triglycerides concentration > 150 mg/dl.

  5. Hypertension

    Time frame: 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.

  6. Body mass index

    Time frame: 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.

Secondary outcomes

  1. Exercise time (including exergaming time)

    Time frame: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).

    Total minutes of exercise time and exergaming time per week.

  2. Sedentary time

    Time frame: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).

    Total minutes of sedentary time per week.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Zhao, PhD

CONTACT

[email protected]

+86-13170322723

Jiuling Li, Masters

CONTACT

[email protected]

+81-7083895217

Sponsors and collaborators

Lead sponsor

Guangzhou University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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