Clinical trial NCT05160025: Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease
Official title: Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-12-16
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures design
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback
timeFrame: Session 1 - During the 8-minute feedback bout
measure: Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition
timeFrame: Session 1 - During the 8-minute self-competition bout
measure: Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition
timeFrame: Session 1 - During the 8-minute other-competition bout
measure: Motivation (Intrinsic Motivation Inventory) - Feedback
timeFrame: Session 1 - Immediately after completing the 8-minute feedback bout
measure: Motivation (Intrinsic Motivation Inventory) - Self-Competition
timeFrame: Session 1 - Immediately after completing the 8-minute self-competition bout
measure: Motivation (Intrinsic Motivation Inventory) - Other-Competition
timeFrame: Session 1 - Immediately after completing the 8-minute other-competition bout
measure: Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Feedback
timeFrame: Session 1 - During the 8-minute feedback bout
measure: Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition
timeFrame: Session 1 - During the 8-minute self-competition bout
measure: Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition
timeFrame: Session 1 - During the 8-minute other-competition bout
measure: 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
timeFrame: Session 1 - During the 8-minute feedback bout
measure: 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
timeFrame: Session 1 - During the 8-minute self-competition bout
measure: 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
timeFrame: Session 1 - During the 8-minute other-competition bout
Secondary outcomes:
measure: Rating of Perceived Exertion - Feedback (Start)
timeFrame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout
measure: Rating of Perceived Exertion - Feedback (Middle)
timeFrame: Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout
measure: Rating of Perceived Exertion - Feedback (End)
timeFrame: Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout
measure: Rating of Perceived Exertion - Self-Competition (Start)
timeFrame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout
measure: Rating of Perceived Exertion - Self-Competition (Middle)
timeFrame: Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout
measure: Rating of Perceived Exertion - Self-Competition (End)
timeFrame: Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout
measure: Rating of Perceived Exertion - Other-Competition (Start)
timeFrame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout
measure: Rating of Perceived Exertion - Other-Competition (Middle)
timeFrame: Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout
measure: Rating of Perceived Exertion - Other-Competition (End)
timeFrame: Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout
measure: Competitiveness (Multidimensional Competitive Orientation Inventory)
timeFrame: Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure)
measure: Ranking of Perceived Effort
timeFrame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
measure: Ranking of Enjoyment
timeFrame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
measure: Audio Recordings of Exercise Experience
timeFrame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Other outcomes:
measure: UPDRS-III Subscale
timeFrame: Collected once at start of the session (Repeat of Baseline Outcome Measure)
measure: Physical Activity Scale for the Elderly
timeFrame: Collected once at start of the session (Repeat of Baseline Outcome Measure)
measure: Geriatric Depression Scale (Short Form)
timeFrame: Collected once during screening (Repeat of Baseline Outcome Measure)
Locations:
city: Newark
country: United States
facility: Rutgers School of Health Professions
state: New Jersey
Study officials:
affiliation: Rutgers School of Health Professions
name: Judith E Deutsch
role: PRINCIPAL_INVESTIGATOR
References: