Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

Study Overview
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Brief Summary
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This study has three objectives about persons with Parkinson's Disease during bicycling: Determine the effect of visual feedback and competition during virtual bicycling on neuromuscular and cardiovascular intensity Determine the effect of visual-feedback and competition during virtual bicycling on the user experience of motivation, enjoyment & perception of exercise intensity Determine if attention differs during visual feedback compared to competition virtual bicycling

Detailed Description
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Participants will attend one sessions lasting about 2-3 hours. They will complete movement assessments and questionnaires about physical activity. They will then exercise exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 8 minutes and will be followed by questionnaires about the participant's experience.

Official Title
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Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Virtual reality bicycling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson's disease following the UK Brain Bank Diagnostic Criteria, Hoehn and Yahr stages II-III, 45-80 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 neurological disorder other than Parkinson Disease, 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 9 or more on GDS screening tool).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Repeated measures design
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 8 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. Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 8 minutes each.<br>|

What is the study measuring?
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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 8-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 8-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 8-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 8-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 8-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 8-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 8-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 8-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 8-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 are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%). | Session 1 - During the 8-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 are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%). | Session 1 - During the 8-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 are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%). | Session 1 - During the 8-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 8-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 (4-minute mark) of the 8-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 (8-minute mark) of the 8-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 8-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 (4-minute mark) of the 8-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 (8-minute mark) of the 8-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 8-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 (4-minute mark) of the 8-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 (8-minute mark) of the 8-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. | Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure) | 
| 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. Quantitative and qualitative analysis of recordings were not conducted. However, sample quotes representing constructs of the Intrinsic Motivation Inventory will be included in future publications. | 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
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Keywords Provided by Centre Hospitalier Valida
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parkinson disease, parkinsonian disorders, Basal ganglia disease, Brain diseases, central nervous system diseases, nervous system diseases, movement disorders, synucleinopathies, neurodegenerative diseases