Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160025
• Other study ID #: Pro2021001412
• Secondary ID: 1F30AG072807-011
• Status: Completed
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: February 17, 2023

Study information

• Verified date: December 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Rutgers School of Health Professions	Newark	New Jersey

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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
Primary	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
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.	Session 1 - Immediately after completing the 8-minute feedback bout
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.	Session 1 - Immediately after completing the 8-minute self-competition bout
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.	Session 1 - Immediately after completing the 8-minute other-competition bout
Primary	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
Primary	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
Primary	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
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 (%).	Session 1 - During the 8-minute feedback bout
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 (%).	Session 1 - During the 8-minute self-competition bout
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 (%).	Session 1 - During the 8-minute other-competition bout
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.	Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout
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.	Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout
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.	Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout
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.	Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout
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.	Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout
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.	Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout
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.	Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout
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.	Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout
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.	Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout
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.	Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure)
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.	Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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.	Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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.	Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition