Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Virtual reality 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07107
      • Rutgers School of Health Professions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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)
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPDRS-III Subscale	Description of Motor Performance Scored from 0-108 a lower score is better outcome	Collected once at start of the session (Repeat of Baseline Outcome Measure)
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.	Collected once at start of the session (Repeat of Baseline Outcome Measure)
Geriatric Depression Scale (Short Form)	15 item inventory to rate depression (scored from 0-15 with a lower score being better)	Collected once during screening (Repeat of Baseline Outcome Measure)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Judith E Deutsch, Rutgers School of Health Professions

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: movement disorders; synucleinopathies; nervous system diseases; Brain diseases; parkinson disease; central nervous system diseases; neurodegenerative diseases; parkinsonian disorders; Basal ganglia disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Pro2021001412; 1F30AG072807-01 (U.S. NIH Grant/Contract); 1R15AG063348-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Immediately following completion of the proposed study the investigators will submit a de-identified data set of the protocol and links to published papers.
• IPD Sharing Time Frame: The investigators will make study data available immediately following completion.
• IPD Sharing Access Criteria: Open Access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No