Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556784
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Immersive Virtual Reality Exergames and Office Workers Cardiometabolic Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
At-home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers Protocol for a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None