Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health

NCT06556784 | Not Yet Recruiting

• 1 other identifier: VRGOWH2024Z
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exergaming; Metabolic Syndrome

Keywords

Immersive virtual reality; Physical activity; Office workers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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).

Study Arms (2)

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.

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.

Interventions

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.

12-week at-home immersive virtual reality exergame

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University: lead

Related Publications (1)

• 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.

  PMID: 39832174 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Central Study Contacts

Jing Zhao, PhD

CONTACT

+86-13170322723; zhaojing@gzhu.edu.cn

Jiuling Li, Masters

CONTACT

+81-7083895217; hebitoto123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share