- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416839
VR Exercise Intervention in a Workplace Setting (VRW)
May 10, 2024 updated by: XRWorkout, Inc
Virtual Reality Fitness Program to Promote Active Lifestyle and Psychological Wellbeing
This research study is designed to better understand how a virtual reality (VR) exercise application may influence overall physical activity and well-being.
VR games can make exercise more enjoyable and interactive, which has been shown to increase engagement in physical activity.
Adult participants will do a progressive exercise program and report on overall physical activity, health, and psychological wellbeing.
The intervention is expected to have a positive impact on these lifestyle factors.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
irtual Reality (VR) fitness applications are promising interventions to promote exercise in a home setting.
Multiplayer fitness games for virtual reality platforms, addresses several common challenges associated with decreased exercise adherence such as social accountability, transportation, weather, gym memberships, and self-consciousness.
This study aims to assess the impact of regular usage of a commercially available virtual reality fitness application on quality of life measures, including physical activity, health, and well-being.
This study will enroll healthy participants, age 18- 50 years old, and they will be issued a Quest 2 virtual reality headset and given access to the virtual reality fitness application (VRWorkout - VRW).
Participants will be asked to use VRW on a regular and progressive basis over a six-week period and to complete surveys about physical activity and wellbeing over a 9-week period.
The activity completed within VRW is based on participant choice.
A suggested progression schedule will be provided, but not enforced.
This study of healthy working individuals, is foundational to assessing whether immersive fitness applications may be used as a lifestyle intervention to increase overall physical activity and well-being.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julia Scott, PhD
- Phone Number: +1 (650)302-7285
- Email: julia@xrworkout.ai
Study Contact Backup
- Name: Alex Azzi
- Email: Alex@xrworkout.ai
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39056
- Recruiting
- University of Mississippi Medical Center
-
Contact:
- Jacob Daniels, PhD, PT
- Phone Number: 601-815-4038
- Email: jbdaniels@umc.edu
-
Contact:
- Jennifer Reneker, PhD, PT
- Phone Number: (601) 984-6326
- Email: jreneker@umc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Individuals who have been advised by a healthcare provider that they should not participate in moderate to strenuous physical activity for any reason
- Individuals with history of seizures with photosensitivity
- Individuals with diagnosis of uncontrolled metabolic disorders
- Current lice infestation
- Current eye infection
- Body Mass Index above 30 (obese)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR Exercise
This arm will use a VR exercise game that increases in frequency, intensity and duration with each week of the intervention.
|
Participation in high intensity interval training delivered on a virtual reality headset over six-week period.
Participants may exercise with others in the multiplayer mode and use any feature of the application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Questionnaire
Time Frame: Weeks 1, 3, 5, 7, and 9
|
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
A higher score indicates more physical activity.
|
Weeks 1, 3, 5, 7, and 9
|
World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame: Weeks 1, 3, 5, 7, and 9
|
The WHO-5 is a short, self-administered, and positively worded 6 point scale designed to measure the level of subjective well-being over the last two weeks.
A higher score indicates better well-being.
|
Weeks 1, 3, 5, 7, and 9
|
Self-Efficacy for Exercise
Time Frame: Week 1 and Week 9
|
This 10 point scale is a self-report on 9 items of exercise self-efficacy.
A higher score indicates greater self-efficacy.
|
Week 1 and Week 9
|
36-Item Short Form Health Survey (SF-36)
Time Frame: Week 1 and Week 9
|
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Each of the 36 questions has a yes or no answer or a linear rating scale.
These measures rely upon patient self-reporting and have been widely used.
A higher score indicates better health.
|
Week 1 and Week 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health and Work Questionnaire
Time Frame: Weeks 1, 3, 5, 7, and 9
|
The Health and Work Questionnaire was developed to assess various aspects of productivity without completely relying on direct subjective estimation.
It is a multidimensional measure of productivity.
It consists of 24 questions, several of which were multi-part questions, comprising six subscales.
High scores indicate greater productivity or health.
|
Weeks 1, 3, 5, 7, and 9
|
Job Affect Well-being Scale
Time Frame: Week 1 and Week 9
|
The Job-related Affective Well-being Scale (JAWS) is a scale designed to assess people's emotional reactions to their job.
It asks them to indicate for each of 30 emotions (20 emotions in the short form) how often they have experienced them in the past 30 days.
Higher scores indicate more positive affects related to work.
|
Week 1 and Week 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacob Daniels, PhD, PT, University of Mississippi Medical Center
- Study Chair: Jennifer Reneker, PhD, PT, University of Mississippi Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2024
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 10, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 10, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XRW001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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