Immersive Virtual Reality Bicycling for Healthy Adults

Study Overview
=================
Brief Summary
-----------------
This study has four objectives about healthy younger and older adults during immersive virtual reality bicycling: Determine the effect of visual feedback and competition for younger healthy adults during virtual bicycling on user experience, motivation, enjoyment, perception of effort, and neuromuscular and cardiovascular intensity Determine the effect of visual feedback and competition for older healthy adults during virtual bicycling on user experience, motivation, enjoyment, perception of effort, and neuromuscular and cardiovascular intensity Compare younger and older during visual feedback and competition bicycling in terms of: user experience, motivation, enjoyment, perception of effort, neuromuscular and cardiovascular intensity Determine if attention differs in visual feedback bicycling compared to competition bicycling for younger and older healthy adults

Detailed Description
-----------------
Participants will attend one session lasting about 1.5 hours. They will complete a competitiveness assessment and a questionnaire about physical activity. They will then exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 5 minutes and will be followed by questionnaires about the participant's experience.

Official Title
-----------------
Enhancing Exercise Intensity, Motivation and Enjoyment for Younger and Older Healthy Adults (VCycle-Competition-HA)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Virtual reality bicycling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21-75 years old, Able to ride a stationary upright bicycle, Able to sign informed consent. Exclusion Criteria: Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or any other neurological disorder Are unable to follow directions or sign a consent form, Do not have adequate vision or hearing ability to see or hear a television, Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle, Have any other medical condition that prevents bicycling, Have moderate depression (score of 10 or more on PHQ-9 screening tool)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Virtual Reality Bicycling<br>This is a single arm study in which all participants will execute the same three bicycling tasks over one session. Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 5 minutes each. | Other: Virtual reality bicycling<br>* This is a single arm study in which all participants will execute the same three bicycling tasks over one session (see arm/group description).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Feedback | Bicycling cadence collected continuously (1 value per second, 1 Hz) | Session 1 - During the 5-minute feedback bout | 
| Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Self-Competition | Bicycling cadence collected continuously (1 value per second, 1 Hz) | Session 1 - During the 5-minute self-competition bout | 
| Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Other-Competition | Bicycling cadence collected continuously (1 value per second, 1 Hz) | Session 1 - During the 5-minute other-competition bout | 
| Motivation (Intrinsic Motivation Inventory) - Feedback | Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation. | Session 1 - Immediately after completing the 5-minute feedback bout | 
| Motivation (Intrinsic Motivation Inventory) - Self-Competition | Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation. | Session 1 - Immediately after completing the 5-minute self-competition bout | 
| Motivation (Intrinsic Motivation Inventory) - Other-Competition | Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation. | Session 1 - Immediately after completing the 5-minute other-competition bout | 
| Cardiovascular Intensity (Heart rate, beats per minute) - Feedback | Heart rate collected continuously (1 value per second, 1 Hz) | Session 1 - During the 5-minute feedback bout | 
| Cardiovascular Intensity (Heart rate, beats per minute) - Self-Competition | Heart rate collected continuously (1 value per second, 1 Hz) | Session 1 - During the 5-minute self-competition bout | 
| Cardiovascular Intensity (Heart rate, beats per minute) - Other-Competition | Heart rate collected continuously (1 value per second, 1 Hz) | Session 1 - During the 5-minute other-competition bout | 
| Visual Attention (infrared eye-tracking data representing gaze positions in a 3D coordinate plane to be used in calculating dwell time in regions of interest in the virtual simulation) - Feedback | 3D gaze positions measured continuously (50 values per second, 50 Hz) | Session 1 - During the 5-minute feedback bout | 
| Visual Attention (infrared eye-tracking data representing gaze positions in a 3D coordinate plane to be used in calculating dwell time in regions of interest in the virtual simulation) - Self-Competition | 3D gaze positions measured continuously (50 values per second, 50 Hz) | Session 1 - During the 5-minute self-competition bout | 
| Visual Attention (infrared eye-tracking data representing gaze positions in a 3D coordinate plane to be used in calculating dwell time in regions of interest in the virtual simulation) - Other-Competition | 3D gaze positions measured continuously (50 values per second, 50 Hz) | Session 1 - During the 5-minute other-competition bout | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of Perceived Exertion - Feedback (start) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 - Immediately at the start (0-minute mark) of the 5-minute feedback bout | 
| Rating of Perceived Exertion - Feedback (middle) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 - At the midpoint (2.5-minute mark) of the 5-minute feedback bout | 
| Rating of Perceived Exertion - Feedback (end) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 - At the endpoint (5-minute mark) of the 5-minute feedback bout | 
| Rating of Perceived Exertion - Self-Competition (start) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 - Immediately at the start (0-minute mark) of the 5-minute self-competition bout | 
| Rating of Perceived Exertion - Self-Competition (middle) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 -At the midpoint (2.5-minute mark) of the 5-minute self-competition bout | 
| Rating of Perceived Exertion - Self-Competition (end) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 -At the end (5-minute mark) of the 5-minute self-competition bout | 
| Rating of Perceived Exertion - Other-Competition (start) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 -Immediately at the start (0-minute mark) of the 5-minute other-competition bout | 
| Rating of Perceived Exertion - Other-Competition (middle) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 -At the midpoint (2.5-minute mark) of the 5-minute other-competition bout | 
| Rating of Perceived Exertion - Other-Competition (end) | Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion. | Session 1 -At the end (5-minute mark) of the 5-minute other-competition bout | 
| Competitiveness (Multidimensional Competitive Orientation Inventory) | Measured once using the Multidimensional Competitive Orientation Inventory consisting of 12 items from 4 subscales (hyper competitive, self-developmental, anxious, lack of interest) For each subscale, mean scores range from 1-6 with higher scores representing higher levels of that subscale metric. | Session 1 - Collected once at start of session | 
| Ranking of Perceived Effort | Once, after completing all 3 bicycling conditions, participants will be asked in which of the 3 bicycling conditions they felt they worked the hardest. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition in which they felt they worked the hardest and a 3 indicating the condition in which they felt they worked the least hard. | Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition | 
| Ranking of Enjoyment | Once, after completing all 3 bicycling conditions, participants will be asked which of the 3 bicycling conditions they liked the best. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition they liked the best and a 3 indicating the condition they liked the least. | Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition | 
| Audio recordings of exercise experience | Once, after completing all 3 bicycling conditions, participants will be asked about their exercise experience. Their responses will be audio recorded to be coded and analyzed qualitatively for themes. | Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
competition, exercise, bicycling, aging, virtual reality