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Completed

NCT Number: NCT05160025

Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers School of Health Professions

Newark, New Jersey, 07107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual reality bicycling

Other

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.

Primary outcomes

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

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

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

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

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

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

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

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

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

  4. Motivation (Intrinsic Motivation Inventory) - Feedback

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

    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.

  5. Motivation (Intrinsic Motivation Inventory) - Self-Competition

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

    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.

  6. Motivation (Intrinsic Motivation Inventory) - Other-Competition

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

    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.

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

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

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

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

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

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

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

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

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

  10. 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

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

    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 (%).

  11. 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

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

    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 (%).

  12. 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

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

    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 (%).

Secondary outcomes

  1. Rating of Perceived Exertion - Feedback (Start)

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

    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.

  2. Rating of Perceived Exertion - Feedback (Middle)

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

    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.

  3. Rating of Perceived Exertion - Feedback (End)

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

    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.

  4. Rating of Perceived Exertion - Self-Competition (Start)

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

    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.

  5. Rating of Perceived Exertion - Self-Competition (Middle)

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

    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.

  6. Rating of Perceived Exertion - Self-Competition (End)

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

    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.

  7. Rating of Perceived Exertion - Other-Competition (Start)

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

    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.

  8. Rating of Perceived Exertion - Other-Competition (Middle)

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

    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.

  9. Rating of Perceived Exertion - Other-Competition (End)

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

    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.

  10. Competitiveness (Multidimensional Competitive Orientation Inventory)

    Time frame: 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.

  11. Ranking of Perceived Effort

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

    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.

  12. Ranking of Enjoyment

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

    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.

  13. Audio Recordings of Exercise Experience

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

    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.

Other outcomes

  1. UPDRS-III Subscale

    Time frame: Collected 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

  2. Physical Activity Scale for the Elderly

    Time frame: Collected 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.

  3. Geriatric Depression Scale (Short Form)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2021
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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