## Protocol Section
### Identification Module
**NCT ID:** NCT06416839

**Acronym:** VRW

**Brief Title:** VR Exercise Intervention in a Workplace Setting

**Official Title:** Virtual Reality Fitness Program to Promote Active Lifestyle and Psychological Wellbeing

#### Organization Study ID Info
**ID:** XRW001
#### Organization
**Class:** INDUSTRY
**Full Name:** XRWorkout, Inc
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Mississippi Medical Center

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** XRWorkout, Inc

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Physical Inactivity

- Psychological Well-Being

- Work-Related Stress

**Keywords:**

- virtual reality

- exercise

- lifestyle factors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This arm will use a VR exercise game that increases in frequency, intensity and duration with each week of the intervention.

**Intervention Names:**

- Behavioral: VR exercise

**Label:** VR Exercise

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VR Exercise

**Description:** 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.

**Name:** VR exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Physical Activity Questionnaire

**Time Frame:** Weeks 1, 3, 5, 7, and 9

**Description:** 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.

**Measure:** World Health Organisation- Five Well-Being Index (WHO-5)

**Time Frame:** Weeks 1, 3, 5, 7, and 9

**Description:** This 10 point scale is a self-report on 9 items of exercise self-efficacy. A higher score indicates greater self-efficacy.

**Measure:** Self-Efficacy for Exercise

**Time Frame:** Week 1 and Week 9

**Description:** 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.

**Measure:** 36-Item Short Form Health Survey (SF-36)

**Time Frame:** Week 1 and Week 9

#### Secondary Outcomes

**Description:** 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.

**Measure:** Health and Work Questionnaire

**Time Frame:** Weeks 1, 3, 5, 7, and 9

**Description:** 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.

**Measure:** Job Affect Well-being Scale

**Time Frame:** Week 1 and Week 9

### Eligibility Module

**Eligibility Criteria:** 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)

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** julia@xrworkout.ai

**Name:** Julia Scott, PhD

**Phone:** +1 (650)302-7285

**Role:** CONTACT

**Contact 2:**

**Email:** Alex@xrworkout.ai

**Name:** Alex Azzi

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jackson

**Contacts:**

***Contact 1:***

- **Email:** jbdaniels@umc.edu

- **Name:** Jacob Daniels, PhD, PT

- **Phone:** 601-815-4038

- **Role:** CONTACT

***Contact 2:***

- **Email:** jreneker@umc.edu

- **Name:** Jennifer Reneker, PhD, PT

- **Phone:** (601) 984-6326

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Mississippi Medical Center

**State:** Mississippi

**Status:** RECRUITING

**Zip:** 39056

#### Overall Officials

**Official 1:**

**Affiliation:** University of Mississippi Medical Center

**Name:** Jacob Daniels, PhD, PT

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Mississippi Medical Center

**Name:** Jennifer Reneker, PhD, PT

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009784

- Term: Occupational Diseases

- ID: D000013315

- Term: Stress, Psychological

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC24

- Name: Occupational Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M1167

- Name: Occupational Stress

- Relevance: HIGH

- As Found: Work Related Stress

- ID: M12719

- Name: Occupational Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000073397

- Term: Occupational Stress

### Misc Info Module

- Version Holder: 2024-05-31
