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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06416839
Other study ID # XRW001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 3, 2024
Est. completion date September 2024

Study information

Verified date May 2024
Source XRWorkout, Inc
Contact Julia Scott, PhD
Phone +1 (650)302-7285
Email julia@xrworkout.ai
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date September 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

Behavioral:
VR exercise
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.

Locations

Country Name City State
United States University of Mississippi Medical Center Jackson Mississippi

Sponsors (2)

Lead Sponsor Collaborator
XRWorkout, Inc University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity Questionnaire 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
Primary World Health Organisation- Five Well-Being Index (WHO-5) 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
Primary Self-Efficacy for Exercise 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
Primary 36-Item Short Form Health Survey (SF-36) 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 Health and Work Questionnaire 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
Secondary Job Affect Well-being Scale 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
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