ExergamingNCT06556784
Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health
A study testing 12-week at-home immersive virtual reality exergame in people with Exergaming and Metabolic Syndrome, run by Guangzhou University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Exergaming, Metabolic Syndrome
- What is being tested?
- 12-week at-home immersive virtual reality exergame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Exergaming, Metabolic Syndrome
- Being tested
- 12-week at-home immersive virtual reality exergame
- Keywords
- Immersive virtual reality, Physical activity, Office workers
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week at-home immersive virtual reality exergameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 12-week at-home immersive virtual reality exergame | Experimental | 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. Receives: Behavioral: 12-week at-home immersive virtual reality exergame |
| 12-week control in awaiting | No intervention | Maintaining regular eating and working habits without making significant changes throughout the 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-density lipoprotein cholesterol (HDL-C)
HDL-C concentration less than 35 mg/dl for men (39 mg/dl for women).
Measured: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Low-density lipoprotein cholesterol (LDL-C)
LDL-C < 160 mg/dl
Measured: 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.
Measured: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Triglycerides
Triglycerides concentration > 150 mg/dl.
Measured: 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.
Measured: 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.
Measured: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Secondary outcomes (2)
Exercise time (including exergaming time)
Total minutes of exercise time and exergaming time per week.
Measured: 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.
Measured: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startApr 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExergamingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Jing, Guangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556784
- Sponsor's protocol ID
- VRGOWH2024Z
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD.
Publications
Zhao J, Yasunaga A, Kaczynski AT, Park H, Luo Y, Li J, Shibata A, Ishii K, Yano S, Oka K, Koohsari MJ. At-Home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 20;14:e64560. doi: 10.2196/64560.
PubMed 39832174
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06556784
- Acronym / sponsor ID
- VRGOWH2024Z
- Conditions
- Exergaming, Metabolic Syndrome
- Keywords
- Immersive virtual reality, Physical activity, Office workers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 12-week at-home immersive virtual reality exergame | Experimental | Behavioral: 12-week at-home immersive virtual reality exergame12-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. |
| 12-week control in awaiting | No intervention | –Maintaining regular eating and working habits without making significant changes throughout the 12 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week at-home immersive virtual reality exergame12-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. | Behavioural | 12-week at-home immersive virtual reality exergame |
Primary outcome
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).
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
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.
Triglycerides
Time frame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).
Triglycerides concentration > 150 mg/dl.
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.
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.
2 secondary outcomes
Exercise time (including exergaming time)
Time frame: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).
Sedentary time
Time frame: Baseline (0 week, self estimation), Mid-follow up (1-6 week), Final follow up (7-12 week).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Derived from this study: PubMed 39832174Zhao J, Yasunaga A, Kaczynski AT, Park H, Luo Y, Li J, Shibata A, Ishii K, Yano S, Oka K, Koohsari MJ. At-Home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 20;14:e64560. doi: 10.2196/64560.
- Individual participant dataSharing planned: No. There is no plan to share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week at-home immersive virtual reality exergame in people with Exergaming and Metabolic Syndrome, run by Guangzhou University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhao, PhD (+86-13170322723, zhaojing@gzhu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-density lipoprotein cholesterol (HDL-C) (time frame: Baseline (0 week), Mid-follow up (6-week), Final follow up (12-week).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06556784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.