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Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05160025
Enrollment
22
Registered
2021-12-16
Start date
2022-10-27
Completion date
2023-02-17
Last updated
2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson disease, parkinsonian disorders, Basal ganglia disease, Brain diseases, central nervous system diseases, nervous system diseases, movement disorders, synucleinopathies, neurodegenerative diseases

Brief summary

This study has three objectives about persons with Parkinson's Disease during bicycling: 1. Determine the effect of visual feedback and competition during virtual bicycling on neuromuscular and cardiovascular intensity 2. Determine the effect of visual-feedback and competition during virtual bicycling on the user experience of motivation, enjoyment & perception of exercise intensity 3. Determine if attention differs during visual feedback compared to competition virtual bicycling

Detailed description

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.

Interventions

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Repeated measures design

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
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-CompetitionSession 1 - During the 8-minute other-competition bout3D 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 (%).
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) - FeedbackSession 1 - During the 8-minute feedback bout3D 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 (%).
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-CompetitionSession 1 - During the 8-minute self-competition bout3D 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 (%).
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - FeedbackSession 1 - During the 8-minute feedback boutBicycling cadence collected continuously (1 value per second, 1 Hz)
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-CompetitionSession 1 - During the 8-minute self-competition boutBicycling cadence collected continuously (1 value per second, 1 Hz)
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-CompetitionSession 1 - During the 8-minute other-competition boutBicycling cadence collected continuously (1 value per second, 1 Hz)
Motivation (Intrinsic Motivation Inventory) - FeedbackSession 1 - Immediately after completing the 8-minute feedback boutIntrinsic 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.
Motivation (Intrinsic Motivation Inventory) - Self-CompetitionSession 1 - Immediately after completing the 8-minute self-competition boutIntrinsic 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.
Motivation (Intrinsic Motivation Inventory) - Other-CompetitionSession 1 - Immediately after completing the 8-minute other-competition boutIntrinsic 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.
Cardiovascular Intensity (Heart Rate, Beats Per Minute) - FeedbackSession 1 - During the 8-minute feedback boutHeart rate collected continuously (1 value per second, 1 Hz)
Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-CompetitionSession 1 - During the 8-minute self-competition boutHeart rate collected continuously (1 value per second, 1 Hz)
Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-CompetitionSession 1 - During the 8-minute other-competition boutHeart rate collected continuously (1 value per second, 1 Hz)

Secondary

MeasureTime frameDescription
Audio Recordings of Exercise ExperienceSession 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling conditionOnce, 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.
Ranking of EnjoymentSession 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling conditionOnce, 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.
Rating of Perceived Exertion - Feedback (Start)Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback boutBorg 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.
Rating of Perceived Exertion - Feedback (Middle)Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback boutBorg 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.
Rating of Perceived Exertion - Feedback (End)Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback boutBorg 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.
Rating of Perceived Exertion - Self-Competition (Start)Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition boutBorg 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.
Rating of Perceived Exertion - Self-Competition (Middle)Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition boutBorg 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.
Rating of Perceived Exertion - Self-Competition (End)Session 1 - At the end (8-minute mark) of the 8-minute self-competition boutBorg 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.
Rating of Perceived Exertion - Other-Competition (Start)Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition boutBorg 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.
Rating of Perceived Exertion - Other-Competition (Middle)Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition boutBorg 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.
Rating of Perceived Exertion - Other-Competition (End)Session 1 - At the end (8-minute mark) of the 8-minute other-competition boutBorg 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.
Competitiveness (Multidimensional Competitive Orientation Inventory)Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure)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.
Ranking of Perceived EffortSession 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling conditionOnce, 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.

Other

MeasureTime frameDescription
UPDRS-III SubscaleCollected once at start of the session (Repeat of Baseline Outcome Measure)Description of Motor Performance Scored from 0-108 a lower score is better outcome
Physical Activity Scale for the ElderlyCollected once at start of the session (Repeat of Baseline Outcome Measure)Exercise Inventory Questionnaire to measure levels of physical activity. Scores range from 0-793, and higher scores represent higher levels of physical activity over the past 7 days.
Geriatric Depression Scale (Short Form)Collected once during screening (Repeat of Baseline Outcome Measure)15 item inventory to rate depression (scored from 0-15 with a lower score being better)

Countries

United States

Participant flow

Recruitment details

Recruitment start date: October 21, 2022 First participant enrolled and completed study: October 27, 2022 Recruitment end date: February 13, 2023 Final participant enrolled and completed study: February 17, 2023

Participants by arm

ArmCount
Virtual Reality Bicycling
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. Virtual reality bicycling: 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.
21
Total21

Baseline characteristics

CharacteristicVirtual Reality Bicycling
Age, Continuous65.9 years
STANDARD_DEVIATION 6.9
Competitiveness (Multidimensional Competitive Orientation Inventory)
Anxious Subscale
2.3 units on a scale
STANDARD_DEVIATION 1.1
Competitiveness (Multidimensional Competitive Orientation Inventory)
Hyper-Competitive Subscale
2.0 units on a scale
STANDARD_DEVIATION 0.9
Competitiveness (Multidimensional Competitive Orientation Inventory)
Lack of Interest Subscale
2.4 units on a scale
STANDARD_DEVIATION 1.2
Competitiveness (Multidimensional Competitive Orientation Inventory)
Self-Developmental Competitive Subscale
4.3 units on a scale
STANDARD_DEVIATION 1.4
Geriatric Depression Scale (short form)1.29 units on a scale
STANDARD_DEVIATION 1.7
Physical Activity Scale for the Elderly102.27 units on a scale
STANDARD_DEVIATION 57.03
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
19 Participants
Region of Enrollment
United States
21 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
13 Participants
UPDRS-III Subscale40.43 units on a scale
STANDARD_DEVIATION 13.7

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 22
other
Total, other adverse events
0 / 22
serious
Total, serious adverse events
0 / 22

Outcome results

Primary

Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Feedback

Heart rate collected continuously (1 value per second, 1 Hz)

Time frame: Session 1 - During the 8-minute feedback bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingCardiovascular Intensity (Heart Rate, Beats Per Minute) - Feedback109.26 beats per minute (bpm)Standard Deviation 9.9
p-value: <0.001ANOVA
Primary

Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition

Heart rate collected continuously (1 value per second, 1 Hz)

Time frame: Session 1 - During the 8-minute other-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingCardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition114.42 beats per minute (bpm)Standard Deviation 12.4
Primary

Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition

Heart rate collected continuously (1 value per second, 1 Hz)

Time frame: Session 1 - During the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingCardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition115.41 beats per minute (bpm)Standard Deviation 12.6
Primary

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.

Time frame: Session 1 - Immediately after completing the 8-minute feedback bout

ArmMeasureValue (MEDIAN)
Virtual Reality BicyclingMotivation (Intrinsic Motivation Inventory) - Feedback6.06 score on a scale
p-value: 0.111ANOVA
Primary

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.

Time frame: Session 1 - Immediately after completing the 8-minute other-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingMotivation (Intrinsic Motivation Inventory) - Other-Competition6.11 score on a scaleStandard Deviation 0.6
Primary

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.

Time frame: Session 1 - Immediately after completing the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingMotivation (Intrinsic Motivation Inventory) - Self-Competition6.13 score on a scaleStandard Deviation 0.6
Primary

Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback

Bicycling cadence collected continuously (1 value per second, 1 Hz)

Time frame: Session 1 - During the 8-minute feedback bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingNeuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback85.44 revolutions per minute (rpm)Standard Deviation 13.7
p-value: <0.001ANOVA
Primary

Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition

Bicycling cadence collected continuously (1 value per second, 1 Hz)

Time frame: Session 1 - During the 8-minute other-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingNeuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition93.83 revolutions per minute (rpm)Standard Deviation 17.1
Primary

Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition

Bicycling cadence collected continuously (1 value per second, 1 Hz)

Time frame: Session 1 - During the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingNeuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition92.97 revolutions per minute (rpm)Standard Deviation 16.3
Primary

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 (%).

Time frame: Session 1 - During the 8-minute feedback bout

ArmMeasureValue (MEDIAN)
Virtual Reality BicyclingVisual 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) - Feedback76.70 percentage of total valid gazes
p-value: >0.05ANOVA
Primary

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 (%).

Time frame: Session 1 - During the 8-minute other-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingVisual 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-Competition77.89 percentage of total valid gazesStandard Deviation 9.2
Primary

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 (%).

Time frame: Session 1 - During the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingVisual 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-Competition79.20 percentage of total valid gazesStandard Deviation 8.8
Secondary

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.

Time frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition

Secondary

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.

Time frame: Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure)

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality BicyclingCompetitiveness (Multidimensional Competitive Orientation Inventory)Lack of Interest Subscale2.4 score on a scaleStandard Deviation 1.2
Virtual Reality BicyclingCompetitiveness (Multidimensional Competitive Orientation Inventory)Anxious Subscale2.3 score on a scaleStandard Deviation 1.1
Virtual Reality BicyclingCompetitiveness (Multidimensional Competitive Orientation Inventory)Hyper-Competitive Subscale2.0 score on a scaleStandard Deviation 0.9
Virtual Reality BicyclingCompetitiveness (Multidimensional Competitive Orientation Inventory)Self-Developmental Competitive Subscale4.3 score on a scaleStandard Deviation 1.4
Secondary

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.

Time frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Virtual Reality BicyclingRanking of EnjoymentLiked the Competition against Self Condition the Best8 Participants
Virtual Reality BicyclingRanking of EnjoymentLiked the Competition against Others Condition the Best7 Participants
Virtual Reality BicyclingRanking of EnjoymentLiked the Feedback Condition the Best6 Participants
p-value: >0.05Chi-squared
Secondary

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.

Time frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Virtual Reality BicyclingRanking of Perceived EffortReported Competition against Self Condition as Most Effortful11 Participants
Virtual Reality BicyclingRanking of Perceived EffortReported Competition against Others Condition as Most Effortful8 Participants
Virtual Reality BicyclingRanking of Perceived EffortReported Feedback Condition as Most Effortful2 Participants
p-value: >0.05Chi-squared
Secondary

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.

Time frame: Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout

ArmMeasureValue (MEDIAN)
Virtual Reality BicyclingRating of Perceived Exertion - Feedback (End)14.0 score on a scale
p-value: 0.004ANOVA
Secondary

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.

Time frame: Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Feedback (Middle)12.62 score on a scaleStandard Deviation 2.3
Secondary

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.

Time frame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Feedback (Start)8.43 score on a scaleStandard Deviation 2
Secondary

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.

Time frame: Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout

ArmMeasureValue (MEDIAN)
Virtual Reality BicyclingRating of Perceived Exertion - Other-Competition (End)15.0 score on a scale
Secondary

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.

Time frame: Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Other-Competition (Middle)13.57 score on a scaleStandard Deviation 2.5
Secondary

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.

Time frame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Other-Competition (Start)9.0 score on a scaleStandard Deviation 2.2
Secondary

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.

Time frame: Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Self-Competition (End)15.57 score on a scaleStandard Deviation 2
Secondary

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.

Time frame: Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Self-Competition (Middle)13.81 score on a scaleStandard Deviation 1.7
Secondary

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.

Time frame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingRating of Perceived Exertion - Self-Competition (Start)8.67 score on a scaleStandard Deviation 2.2
Other Pre-specified

Geriatric Depression Scale (Short Form)

15 item inventory to rate depression (scored from 0-15 with a lower score being better)

Time frame: Collected once during screening (Repeat of Baseline Outcome Measure)

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingGeriatric Depression Scale (Short Form)1.29 score on a scaleStandard Deviation 1.7
Other Pre-specified

Physical Activity Scale for the Elderly

Exercise Inventory Questionnaire to measure levels of physical activity. Scores range from 0-793, and higher scores represent higher levels of physical activity over the past 7 days.

Time frame: Collected once at start of the session (Repeat of Baseline Outcome Measure)

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingPhysical Activity Scale for the Elderly102.27 score on a scaleStandard Deviation 57
Other Pre-specified

UPDRS-III Subscale

Description of Motor Performance Scored from 0-108 a lower score is better outcome

Time frame: Collected once at start of the session (Repeat of Baseline Outcome Measure)

ArmMeasureValue (MEAN)Dispersion
Virtual Reality BicyclingUPDRS-III Subscale40.43 score on a scaleStandard Deviation 13.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026