Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)
Phase: NA
Conditions: Parkinson Disease
Sponsor: Rutgers, The State University of New Jersey

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Judith Deutsch 
 
 
 
 
IMMERSIVE VIRTUAL REALITY BICYCLING FOR PERSONS 
WITH PARKINSON'S DISEASE 
 
 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
NCT05160025 
 
 
 
 
Newark, New Jersey, USA 
 
October 24, 2023 
 

Protocol Title: Enhancing Exercise Intensity, Motivation and Enjoyment for Persons with PD (VCycle-
Competition)
Protocol Version Date: v5 1.18.23;          Protocol # - Pro2021001412
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INTERVENTIONAL
RESEARCH PROTOCOL TEMPLATE
(HRP-503a)
STUDY INFORMATION

Title of Project:
Enhancing Exercise Intensity, Motivation and Enjoyment for Persons with PD (VCycle-
Competition)

Principal Investigator Name
Judith Deutsch PT PhD FAPTA

Principal Investigator Div. & Dept.
Rutgers School of Health Professions
Dept. of Rehabilitation and Movement Sciences
Professor and Director Rivers Lab

Principal Investigator Contact Info: 
deutsch@shp.rutgers.edu
65 Bergen Street SSB 736
973-972-2373

Protocol Version and Date:
            [v5 1.18.23]
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Protocol Title: Enhancing Exercise Intensity, Motivation and Enjoyment for Persons with PD (VCycle-
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Table of Contents 
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue
1.0
Research Design
1.1
Purpose/Specific Aims
1.2
Research Significance
1.3
Research Design and Methods
1.4
Preliminary Data
1.5
Sample Size Justification
1.6
Study Variables
1.7
Specimen Collection
1.8
Data Collection
1.9
Interviews, Focus Groups, or Surveys and/or Observations
2.0
Project Management
2.1
Research Staff and Qualifications
2.2
Research Staff Training
2.3
Resources Available
2.4
Research Sites
3.0
Multi Center Research
4.0
Subject Considerations
4.1
Subject Selection and Enrollment Considerations
4.2
Obtaining Identifiable Information About Non-Subjects
4.3
Number of Subjects
4.4
Consent Procedures
4.5
Special Consent Populations
4.6
Economic Burden and/or Compensation For Subjects
4.7
Risks and Benefits to Subjects
5.0
Special Considerations
5.1
Health Insurance Portability and Accountability Act (HIPAA)
5.2
Family Educational Rights and Privacy Act (FERPA)
5.3
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
5.4
General Data Protection Regulation (GDPR)
5.5
NJ Access to Medical Research Act (Surrogate Consent)
6.0
Data Management Plan
6.1
Data Analysis
6.2
Data Security
6.3
Data and Safety Monitoring
6.4
Reporting Results
6.5
Secondary Use of Data
7.0
Research Repositories - Specimen and/or Data
8.0
Approvals/Authorizations
9.0
Bibliography
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1.0 Research Design
1.1 Purpose/Specific Aims 
The short-term goal of this project is to gain insight into specific strategies of VR-based 
rehabilitation to increase motivation and intensity for persons with PD during a cycling task.  The 
long-term goal of this study is to determine the essential elements in designing a training 
circuit for persons with PD to promote mobility and fitness resulting increased activity and 
participation. The short-term goals will be achieved through two primary aims that build upon 
the parent grant (1-2) and further refined through a mechanistic aim about the role of attention in 
explaining behavior in the VE (3).
We aim to build upon our work in PD and that of others in persons post stroke by using augmented 
visual feedback and competition to increase exercise intensity and motivation while cycling in a 
virtual environment. 
Aim 1: Determine the effect of visual feedback and competition (self or others) during virtual 
bicycling on neuromuscular (cycling cadence) and cardiovascular (% max heart rate) intensity
Hypothesis:  Competition will produce higher neuromuscular and cardiovascular intensity 
compared to feedback.
Aim 2: Determine the effect of visual-feedback and competition (self or others) during virtual 
bicycling on the user experience of motivation & enjoyment (Intrinsic Motivation Inventory: IMI) & 
perception of exercise intensity (Borg Scale)
Hypotheses: Competition will elicit a higher motivation and enjoyment compared to visual 
feedback.  Competition will result in lower perceived exertion compared to visual feedback.
Aim 3: Determine if attention differs (dwell time percentage) in augmented visual feedback 
bicycling compared to competition (self or others) virtual bicycling
Hypothesis: Attention will be higher during competition virtual bicycling when compared to 
augmented bicycling.
A. Objectives (see above)
B. Hypotheses / Research Question(s) (see above)
1.2 Research Significance (Briefly describe the following in 500 words or less)
Parkinson’s Disease (PD) is a neurodegenerative condition that affects over 10 million individuals
worldwide. [1] In addition to pharmacotherapy, intense (cardiovascular and neuromuscular) exercise is 
recommended for persons with PD. Studies investigating the positive neuroplastic effects of intense 
exercise in animals [2] have been extended to humans regarding improved brain connectivity and 
upregulation of brain-derived neurotrophic factor. [3, 4] In addition to neuroplastic effects, exercise has 
been shown to have positive clinical benefits in reducing PD severity and improving motor and cognitive 
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function in persons with PD. [4-6] Specifically, bicycling has been shown to improve balance and 
mobility and reduce both motor symptoms, and disease severity for persons with PD. [7-10] In achieving 
and adhering to the intensity of bicycling required to benefit from the training, factors such as the user 
experience of exercise, specifically motivation, [11] enjoyment, and perceived exertion need to be 
considered. This is important as adherence to routine exercise is challenging for persons with PD. [12, 13] 
One method that may enhance exercise intensity for persons with PD is bicycling augmented with a 
virtual environment (VE). VEs serve as an interactive context to engage the participant in the exercise 
task. [14] This is because VEs provide visual feedback and cueing that may drive the intensity of the 
exercise. Specifically, we have shown that neuromuscular cycling intensity (cadence) was increased with 
visual feedback in short bouts of bicycling in a VE (see Pilot Data). [15] To maintain engagement for 
longer bouts, competition may provide an additive effect to visual feedback in the VE. 
While motor and cognitive outcomes have been documented for persons with PD interacting with 
virtual environments, [16, 17] less is known about visual attention of persons with PD during motor tasks 
in VEs. Though visual attention has been studied in persons with PD, [18] only a few studies have 
investigated visual attention in VEs. [19] To address this knowledge gap, we will be the first lab to 
investigate eye movements as a surrogate of attention in persons with PD during virtual reality (VR) 
bicycling to study a mechanistic explanation for behavioral changes.
The ultimate goal of this research is to improve the well-being of persons with PD by making 
intense exercise more practical and enjoyable for them. It is significant that we bring inter-disciplinary 
expertise in understanding virtual environments and the demands of implementing the technology in 
clinical practice. By developing and validating virtual reality simulations that are enjoyable, motivating, 
and facilitate intense exercise, we aim to remove barriers associated with exercise for persons with PD 
and improve activity and participation as well as promote a healthy lifestyle. Being a valuable adjuvant to 
pharmacotherapy in addressing the motor and nonmotor symptoms of PD, intense exercise measured by 
neuromusculoskeletal and cardiovascular criteria may ultimately have beneficial therapeutic effects in 
decreasing disease severity and improving well-being.
1.3 Research Design and Methods
This is a controlled study within subject design. It is a single cohort.
Figure 1:  An overview of the study protocol in a single session. There are three trials 
competition (self or others) and feedback. 
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A. Research Procedures
After phone screening and in-person consent, participants will complete baseline assessments 
related to personal factors, clinical ratings of PD, and baseline simulation sickness. Then 
participants will familiarize themselves with three different bicycling conditions. After 
familiarization, participants will complete each bicycling condition in a counter-balanced random 
order. Each condition will last 8 minutes (~24 minutes of exercise total) and will be preceded by 
a baseline cadence assessment. For the visual feedback condition, the cyclist will be instructed 
to cycle at a target cadence that will turn the road markers blue. For the competition conditions, 
the participant will be instructed to cycle fast enough to pass a virtual cyclist in the simulation that 
is pedaling at the target cadence. Measurements of cardiovascular (HR) and neuromuscular 
(cycling cadence) intensity and visual attention (eye-tracking data) will be recorded continuously 
during both cycling conditions. Ratings of perceived exertion (RPE) will be collected at the 
beginning, midpoint, and end of each condition. At the end of each cycling bout, motivation & 
enjoyment and simulation sickness will be assessed. Open ended questions about the experience 
in each condition will conclude the session. Participant safety will be carefully monitored. If the 
intensity of the exercise is too high, the cyclists may overexert themselves risking adverse 
cardiovascular events. Therefore, different termination criteria will be implemented to ensure the 
safety of the patient. Participants will also be supervised at all times for safety on the bike. They 
will also be monitored for signs of cybersickness (dizziness, sweating) and be given an 
opportunity to stop at any time.
B. Data Points
See outcome table below (Table 1).
C. Duration for Study and Each Subject
The study will be conducted over 20 months. Participants will attend one data collection session, 
lasting approximately three hours.
D.  Endpoints
See Section 1.10 for the Data Monitoring timeline
1.4 Preliminary Data
In the parent study, data have already been collected from 22 participants with PD bicycling in a fully-
immersive VE using visual feedback. Participants tolerated the HMD well, showing no significant 
difference in simulation sickness scores post-trial compared to baseline.  Participants also reported 
moderate-high scores for several constructs of the IMI at the end of the 5-minute bout, including interest 
& enjoyment, perceived competence, and value & usefulness. Participants also bicycled at a moderate-
high intensity, indicated by an average % HR Max of >55% and a bicycling cadence that was >30% faster 
than their comfortable baseline cadences. 
There are many parallels between the parent study and this project. In particular, we have demonstrated 
our ability to recruit, screen, and clinically test persons with PD.  Furthermore, we have collected time 
series of heart rate and bicycling cadence data during exercise for persons with PD.
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1.5 Sample Size Justification
Power analyses- Sample size for Aim 1: An a priori power analysis was powered upon preliminary cycling 
cadence data published from the lab. [15] The power analysis conducted in G*Power, [20] determined 
that 19 participants would be required to reach a power level of 0.80 (Cohen’s D =0.7, moderate effect 
size). Aim 2: An a priori power analysis powered on motivation and enjoyment (Intrinsic Motivation 
Inventory) [21] with an effect size of 0.75 determined that 16 participants would be required. This effect 
size was adapted from Cikajilo & Potisk 2019, who investigated a fine motor upper extremity task for 
persons with PD in a fully-immersive environment. We used their reported average effect size of the 
different IMI subscales. [22] Aim 3: There are no pilot data (collected by our team or published by others) 
for this aim. An effect size will be calculated from these data to power future studies. Considering all the 
sample size calculations and accounting for a 20% attrition rate, 24 participants will be required for this 
study.
1.6 Study Variables
A. Independent Variables, Interventions, or Predictor Variables
Cycling Mode (Visual feedback versus competition against self and others)
B. Dependent Variables or Outcome Measures
See table below (Table 1):
Neuromuscular Exercise Intensity
Cycling cadence
Measured by the Wahoo sensor on the bicycle crank. Referenced 
to the self-selected cadence to measure the % increase as well as 
the absolute value (Aim 1) 
Cardiovascular Exercise Intensity
Heart Rate (HR) % of maximum
Collected with Garmin or Polar HR monitor worn on the forearm. 
Referenced to age maximum and interpreted as a percent (Aim 1)
  Blood pressure (BP)
Collected manually with upright Braum mercury 
sphygmomanometer (Aim 1)
Perceived Effort
Rating of perceived exertion (RPE)  The Borg Scale of perceived Exertion will be used to collect this 
information. The lowest measure on the scale is 6: no exertion at 
all, and the highest is 20: maximal exertion (Aim 2)
Open Ended Questions
Ranking of 3 conditions and interview for qualitative data (Aim 2)
Motivation
Intrinsic Motivation Inventory (IMI)
Customized motivation inventory capturing 4 constructs including: 
interest & enjoyment, perceived competence, effort & importance, 
value & usefulness. Participants will complete the IMI after each 
condition.  The IMI has been validated for older adults (Aim 2)
Open Ended Questions
Ranking of 3 conditions and interview for qualitative data (Aim 2)
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Attention
Eye-Tracking Data
Collected continuously at 30-50 Hz with HTC Vive Pro Eye, using 
built-in Tobii infrared eye-trackers.  Data will be collected and 
analyzed from 1 minute until the end of the bicycling bout to 
account for acclimation to the VE
Participant Characteristics
UPDRS Motor Score Section III
To quantify motor involvement & disease severity
   Physical Activity Scale for the Elderly   
(PASE)  
To measure participants physical activity at time of testing (can be 
used to classify individuals as high and low exercisers. Used and 
validated to measures activity in persons with PD May be used as 
a co-variate
    Simulator Sickness Questionnaire 
(SSQ)  
To measure adverse events in the immersive virtual environment. 
Has been used to measure simulator sickness in persons with PD
    Multi-Dimensional Competitive            
Orientation Inventory (mCOI)
To measure participant competitiveness (can be used to classify 
individuals as competitive or non-competitive). May be used as a 
covariate
Table 1: Primary Outcome Measures are bolded
1.7 Drugs/Devices/Biologics
NA
1.8 Specimen Collection
NA
1.9 Data Collection
A.
Primary Data Collection

Location: Rutgers Sites: SSB 912, 224, and 210

Non-Rutgers Sites: New York Institute of Technology 
o
Northern Boulevard, PO Box 8000, Old Westbury, NY

Riland Building, Academic Health Care Center Biomechanics Lab 

Process of Data Collection: 
The data collection procedures are described in detail in the screening document and the data 
collection document that were uploaded with this IRB proposal.
Protocol: See Figure 1 above. 
Screening: Prior to the cycling session, participants will be screened over the phone for exercise 
readiness using the Physical Activity Readiness for Everyone scale (PAR-Q+). [23] A positive 
response to 2 or more of the questions will prompt a request for medical clearance for the 
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Protocol Title: Enhancing Exercise Intensity, Motivation and Enjoyment for Persons with PD (VCycle-
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participant.  As depression is prevalent in the PD population and is associated with disability, [24] 
participants will also be screen using the short form of the Geriatric Depression Scale (GDS-15), 
[25] which has been validated in persons with PD. [26] Participants with a score of 9 or more on 
the GDS-15 (indicating moderate depression) will be excluded.  Once cleared, participants will be 
asked to take their medications as normal. Testing will be scheduled at peak medication, 
approximately 2 hours after administration.  
Baseline Assessments: Participants will complete a questionnaire about personal factors 
including age, gender, previous VR use and competitiveness. Competitiveness will be measured 
with a validated 12-item inventory. [27]  Disease severity will be assessed with the motor subscale 
of the UPDRS (UPDRS-III). [28] The simulation sickness questionnaire (SSQ) will be collected at 
baseline and at the end of the final trial to monitor cybersickness. [29]
Familiarization: Participants will don the HMD and bicycle in the three different conditions until 
they execute each cycling task correctly and are accustomed to the HMD and understand the 
Borg Scale. After familiarization, there will be a brief period of rest to restore HR to baseline.
Cycling Conditions 
Baseline cycling cadence will be established for each condition. Participants will cycle at a 
comfortable pace that can be maintained for 30 minutes. This comfortable baseline pace will be 
used to set the target cadence (rate at which the visual markers are presented or rate of the virtual 
competitive cyclist) for participants during the given trial. The target cadence will be set at a pace 
that is 25% higher than comfortable baseline pace. [10, 15]
Visual Feedback Condition: The cyclist will be instructed to cycle at a pace that will turn the 
road markers blue. If the cyclist pedals at a speed that is below the target cadence, the markers 
will remain white. If the cyclist cycles at a pace that is above the target cadence the markers will 
turn from white to blue, serving as visual feedback for the user to maintain the pace. If the cyclist 
pedals too fast (threshold set at 40% greater than the comfortable baseline RPM), the road 
markers will turn from blue to red, serving as visual feedback for the user to slow down. The 
participant will also receive summary information at fixed time intervals about how well they are 
maintaining their cadence in the target range. Explicit instructions will be provided to the user 
before the trial begins.
Competition Condition (Other): The virtual cyclist will be referred to as a virtual agent, since the 
cyclist is not being controlled by another human being. [30] Once the 8-minute trial begins, the 
participant will be instructed to cycle fast enough to pass the virtual agent travelling at their target 
cadence. If the cyclist passes the virtual agent, another agent will appear further ahead on the 
road (travelling at the target cadence) in order to maintain the competitive effect of this cycling 
task. The goal of the activity is to pass as many virtual agents as possible can within the 8-minute 
condition. 
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Competition Condition (Self): This condition is similar to the other competition condition.  
However, participants will be instructed that the virtual agent represents their best time. Therefore, 
the condition is framed as self-competition as the goal is to perform better than their best time by 
passing as many other virtual agents as possible. Since the conditions are counter-balanced, if 
this condition occurs first, participants will be informed that the other virtual agents are modelled 
after an estimation of their best time using data from familiarization. Importantly, the timescale of 
visual information presentation will be identical across the three cycling conditions (all responding 
instantaneously to deviations from the target intensity).
Measurements: Measures of cardiovascular (HR) and neuromuscular (cycling cadence) intensity 
and visual attention (eye-tracking data) will be recorded continuously during both cycling 
conditions. Rating of perceived exertion (RPE) will be collected at the beginning, midpoint, and 
end of each condition. Each condition will last 10 minutes [10] and will be followed by assessment 
of motivation and enjoyment using the Intrinsic Motivation Inventory (IMI) [21, 31] and simulation 
sickness using the SSQ. (Figure 1)
Participant Safety: will be carefully monitored. If the intensity of the exercise is too high, the 
cyclists may overexert themselves risking adverse cardiovascular events. Therefore, different 
termination criteria will be implemented to ensure the safety of the patient (i.e. if RPE > 16 and 
HR > 80% MaxHR, the experiment will be terminated). These criteria are based on ACSM 
guidelines for exercise termination. [32]

Timing and Frequency: Data will be collected in a single session lasting ~3 hours.

Procedures for Audio/Visual Recording: Participants will be recorded during the debriefing 
at the conclusion of each data collection session. These data will subsequently be used to 
analyze the qualitative data. The consent language was incorporated into the consent form. 
Study Instruments: 
Data are collected with known validated instruments (see outcomes table). 

Ethnographic Studies, Interviews, Or Observation: The semi-structured interviews will be 
audio-recorded and transcribed. The data will be loaded into NVivo 12 (QSR International) for 
content analysis. Since the interviews will verify and add depth to the survey findings, we will 
use a combination of conventional and directed content analysis. [33] These content analysis 
procedures include coding transcripts to identify key concepts as initial coding categories, 
developing operational definitions for each concept, and then identifying and labeling patterns 
and themes.  We will verify categories, operational definitions, and themes through team 
coding and discussion.   

Subject Identifiers: All paper instruments will be assigned a code. 
B.
Secondary Data Collection 
NA
1.10 Timetable/Schedule of Events
Months
2
4
6
8
10
12
14
16
18
20
IRB
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Recruitment
Data Collection
Data Monitoring
Data Analysis
Data Interpretation & Writing
2.0 Project Management
2.1 Research Staff and Qualifications
Dr. Deutsch: Project PI and Manager, has history of running clinical studies and supervising personnel 
across skill sets at multiple sites.
Dr. Gallagher: Project PI (external NYIT site, has history of running clinical studies and supervising 
personnel across skill sets)
Dr. Donoghue: Project PI (external NYIT site, has history of running clinical studies and supervising 
personnel across skill sets)
Dr. Parrott: Director of MIST has extensive experience with study design and analysis. Has collaborated 
previously with the team
Dr. Daneault: Consultant, expertise in PD research, has history of data collection and analysis for 
persons with PD
John Palmieri: MD PhD student has experience with technology development and support and data 
collection. Will continue to develop skills with analysis during this project. 
2.2 Research Staff Training
Dr. Deutsch will be responsible for training support staff site.
2.3 Other Resources
Rutgers has sites and adequate facilities to run the study. These are detailed in the facilities section of 
the funded NIH grant application. The Rutgers facilities also have medical support in the event that a 
referral is required. NYIT also has medical support resources if needed.
2.4 Research Sites
Rutgers SHP Rivers Lab (SSB 912), CP (SSB 224), and Motion Analysis Lab (SSB 210)
Non-Rutgers Sites: New York Institute of Technology 

Northern Boulevard, PO Box 8000, Old Westbury, NY
o
Riland Building, Academic Health Care Center Biomechanics Lab 
3.0 Multi Center Research
Yes, an email was sent to the IRB Reliance Administrator. See other sections and forms attached to eIRB 
protocol (HRP-1812a, HRP-830, and HRP-811) for more details on multi center research.
4.0 Subject Considerations
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4.1 Subject Selection and Enrollment Considerations 
A.
Method to Identify Potential Subjects
Upon IRB approval, 35 persons with PD will be recruited from outpatient Parkinson’s groups 
at Kessler Institute and from the JFK Outpatient Clinic and Atlantic Health. We will also post 
the study on websites such as FoxTrialFinder. At NYIT, participants will be recruited from the 
NYIT College of Osteopathic Medicine (NYITCOM) Parkinson’s Program. We will make every 
effort to recruit individuals that represent the ethnic and gender distribution of the populations 
we are examining.
B.
Recruitment Details
Participants will be recruited from the sites indicated above through paper ads, social media posts. 
Emails may be sent to persons who have previously indicated an interest in our studies. A short 
description of the study will be in the body of the text with the approved ad attached. A similar process 
will be used to post on the site.  
C.
Subject Screening
Participants will be screened for eligibility. The screening includes readiness for activity using the 
PARQ+ 2021 and for moderate depression using the Geriatric Depression Scale. The full screening 
document is uploaded. 

Inclusion Criteria
o
Diagnosis of Parkinson’s disease following the UK Brain Bank Diagnostic 
Criteria,
o
Hoehn and Yahr stages II-III, [34] 
o
45-80 years old,
o
Able to ride a stationary upright bicycle, 
o
Able to sign informed consent. 

Exclusion Criteria
o
Have a recent history of severe heart disease, severe lung disease, 
uncontrolled diabetes, traumatic brain injury or neurological disorder other than 
Parkinson Disease,
o
Are unable to follow directions or sign a consent form,
o
Do not have adequate vision or hearing ability to see or hear a television,
o
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,
o
Have any other medical condition that prevents bicycling,
o
Have moderate depression (score of 9 or more on GDS screening tool).
D.
Privacy Protections
PHI (participant name, address, date of birth) will be kept in a separate document. Participant’s age 
and health condition is part of the recruitment. It will only be included with the single data set that is 
used to generate the study codes. 
4.2 Obtaining Identifiable Information About Non-Subjects:
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NA
4.3 Number of Subjects
A. Total Number of Subjects
35 participants will be screened. The study is powered to enroll 24 participants allowing for a 20% 
attrition rate. 
B. Total Number of Subjects If Multicenter Study
18 participants will be screened for collection at the NYIT site.  At NYIT, 12 of the 24 participants will 
be enrolled.
C.
Feasibility
At Rutgers there are other active research programs in the same department that have been 
recruiting participants. There is dedicated parking for participants. 
At the NYIT site, there is a boxing program for individuals with Parkinson Disease and other active 
research programs recruiting participants.  There is also adequate parking for participants.
4.4 Consent Procedures
A. Consent Process

Location of Consent Process
At Rutgers, consent will take place in the SSB 224 and 210.  At NYIT, consent will take place 
in the Riland Building, Academic Health Care Center Biomechanics Lab

Ongoing Consent
The study consists of one session. During the session, participants will be reminded that they 
may withdraw from the study at any time.

Individual Roles for Researchers Involved in Consent
Consent will be obtained at Rutgers by Dr. Deutsch and John Palmieri (MD PhD student). 
Consent will be obtained at NYIT by Dr. Donoghue, Dr. Gallagher, and John Palmieri.

Consent Discussion Duration
Consenting will require 15 minutes.

Coercion or Undue Influence
The procedures will be explained, and participants will be told that they may choose not to 
participate.

Subject Understanding
Participants will be informed about the nature and purpose of the research and given an explanation of 
procedures. After reading the consent form, participants will be asked to describe the elements of the 
study in their own words. If a participant shows a clear understanding of the study, they will be permitted 
to sign the consent form. An experimenter knowledgeable about the research project will be available at 
all times to answer any questions a participant may have. Participants will be told that they are free to 
withdraw at any point during testing.

Protecting Privacy
Participant’s name and health condition is part of the consent form. It will only be included with the 
single data set that is used to generate the study codes. 
B.
Waiver or Alteration of Consent Process 
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
Waiver or Alteration Details

Destruction of Identifiers: NA

Use of Deception/Concealment: NA
a.
Minimal Risk Justification: Study is conducted on a bicycle with monitoring of HR 
exercise intensity and symptoms throughout. 
b.
Alternatives
Participants will not be told the hypothesis of the study as doing so may influence their 
effort and self-reported ratings throughout the session. There are no alternatives. 
Information will not be withheld from participants, as questions that participants may have 
will be addressed at the end of the protocol. 
c.
Subject Debriefing: Participants will be debriefed at the end of each session. 
C.
Documentation of Consent

Documenting Consent
Participants will sign the consent form. Forms will be scanned and saved. 

Waiver of Documentation of Consent (i.e., will not obtain subject’s signature)
NA
4.5 Special Consent/Populations
A.
Enrolling Minors-Subjects Who Are Not Yet Adults: NA
B.
Enrolling Wards of the State: NA
C.
Enrolling Non-English-Speaking Subjects. It is anticipated that most subjects will be English 
speaking, however the study team at Rutgers is fluent in Spanish and able to instruct and consent 
participants. However, all study protocols are in English so the likelihood of enrolling a person 
that is not conversant in English is highly unlikely. 

Process for Non-English-Speaking Subjects
The study team is fluent in Spanish and is able to translate the consent form orally. 

Short Form Consent for Non-English Speakers
Not currently planned.
D.
Enrolling Adults Lacking Decision-Making Capacity (Surrogate Consent)
NA
E.
Special Consent Considerations
NA
4.6 Economic Burden and/or Compensation for Subjects
A. Expenses 
Participants may incur travel expenses to and from the site. There are no other expenses to 
participate in this study.
B.
Compensation/Incentives
Participants will be compensated 30 dollars at the end of the session. 
C.  Compensation Documentation
Participants will be compensated 30 dollars for the session. Documentation at Rutgers will record 
the payment was received.
4.7 Risks of Harm/Potential for Benefits to Subjects
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A.
Description of Risks of Harm to Subjects

Reasonably Foreseeable Risks of Harm
The training studies are non-invasive and pose minimal risk to the participants. They may 
experience occasional fatigue of the lower extremities. We are using one virtual reality 
simulation that will be displayed through a head mounted display. This may pose a small risk 
for nausea or dizziness or present with sweatiness and fatigue. 

Risk of Harm from an Intervention on a Subject with an Existing Condition: NA
We are aware that participants with PD in the study are more likely than the other participants 
to have health conditions that make them more vulnerable to adverse medical events directly 
related to the potential symptoms of nausea or dizziness. Certain other conditions, though not 
necessarily caused by PD, are much more common in people with PD than in the general 
population, including depression, sexual dysfunction, and fatigue. For this reason, we have 
included a screen for depression. Persons with PD who present with moderate depression will 
be excluded. They will be referred to behavioral services for support.

Other Foreseeable Risks of Harm: NA

Observation and Sensitive Information: NA
B.
Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects: NA
C.
Risks of Harm to Non-Subjects: NA
D.
Assessment of Social Behavior Considerations: NA
E.
Minimizing Risks of Harm
It is unlikely that they will lose their balance on the bicycle. A physical therapist will closely monitor the 
participant’s balance. We are using virtual reality simulations that will be displayed through a head 
mounted display. This may pose a small risk for nausea or dizziness or present with sweatiness and 
fatigue. These symptoms will be monitored, and we are prepared to stop data collection to allow 
participants to return to their baseline physiology.  Importantly, it will be clearly explained to participants 
that they may discontinue bicycling at any point in which they experience nausea or dizziness or feel 
hot. Ample time will be given to participants between cycling bouts in the event that they develop 
symptoms. They will be offered an opportunity to sit comfortably with low lighting and given something 
to drink.

Certificate of Confidentiality
To be issued automatically because this is a NIH funded study.
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This 
means that the researchers cannot release or use information, documents, or samples that may identify 
you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless 
you have agreed. This protection includes federal, state, or local civil, criminal, administrative, 
legislative, or other proceedings. An example would be a court subpoena. There are some important 
things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws 
require, such as laws that require reporting of child or elder abuse, some communicable diseases, and 
threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United 
States federal or state government agency from checking records or evaluating programs. The 
Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). 
The Certificate also DOES NOT prevent your information from being used for other research if allowed 
by federal regulations. Researchers may release information about you when you say it is okay. For 
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example, you may give them permission to release information to insurers, medical providers or any 
other persons not connected with the research. The Certificate of Confidentiality does not stop you from 
willingly releasing information about your involvement in this research. It also does not prevent you 
from having access to your own information.

Provisions to Protect the Privacy Interests of Subjects
Participant’s privacy will be carefully guarded. The person performing the consent will explain 
all procedures and personnel involved in data collection. 
F.
Potential Direct Benefits to Subjects
Participants are informed that they may receive no direct benefit from taking part in this study. 
However, investigators may learn better ways to implement rehabilitation and improve fitness for 
persons with PD.  
5.0 Special Considerations
5.1 Health Insurance Portability and Accountability Act (HIPAA)
PHI (name: for tracking reimbursement with gift cards) This will be kept in a separate document. 
Participants age and health condition is part of the data set. It will only be included with the single 
data set that is used to generate the study codes. 
5.2 Family Educational Rights and Privacy Act (FERPA): NA
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations): NA
A.
Special Populations
5.4 General Data Protection Regulation (GDPR): NA
5.5 NJ Access to Medical Research Act (Surrogate Consent): NA
6.0 Data Management Plan
6.1 Data Analysis 
Power analysis was described under sample calculation
Aim / Dependent variable
Factor(s)
Test
Aim 1 – Exercise Intensity
Cycling Cadence 
(baseline-adjusted)
condition 
(feedback & 2 competition 
conditions)
Repeated measures 
ANOVA (Rm-ANOVA) 
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Post-hoc paired t-tests with 
appropriate Bonferroni 
corrections
Heart Rate 
(age-adjusted)
condition 
(feedback & 2 competition 
conditions)
Rm-ANOVA 
Post-hoc paired t-tests with 
appropriate Bonferroni 
corrections
AIM 2 – User Experience of Exercise
Rating of Perceived Exertion 
(RPE)
condition 
(feedback & 2 competition 
conditions)
Rm-ANOVA 
Post-hoc paired t-tests with 
appropriate Bonferroni 
corrections
Motivation (custom IMI Scale)
Interest/Enjoyment
Perceived Competence
Effort/Importance
Value/Usefulness
condition 
(feedback & 2 competition 
conditions)
Rm-ANOVA 
Post-hoc paired t-tests with 
appropriate Bonferroni 
corrections
AIM 3 - Attention
Eye-Tracking Data
Dwell Time Percentage
condition 
(feedback & 2 competition 
conditions)
Rm-ANOVA 
Post-hoc paired t-tests with 
appropriate Bonferroni 
corrections
Bold = Primary comparison Co-variates (exercise readiness, competitiveness, and physical 
activity) may be included in an ANCOVA analysis.  Analysis is simple to parse individual effects 
and then explore the moderating effects of the cycling condition. Due to the sample size, we will 
not attempt to impute for missing measures. Analyses will be carried out with all available data 
for each one of the planned comparisons. 
6.2 Data Security
Participant coding will be generated at Rutgers and stored by the PI on a security encrypted computer. 
De-identified data collected at Rutgers (on paper will be scanned, or digitally) will be uploaded by the 
PI or her designee to shared Box Account for this project.  All paper data will be stored in locked file 
cabinet and digital data on a password protected computer.  Consent forms will also be scanned and 
uploaded to a separate folder from the de-identified data. By the conclusion of the study all data will be 
stored in Box at the Rutgers site. Identifiers connected to the data will be destroyed once all the 
publications from the project are complete and grants have been submitted to extend the work. The 
project PI will make that determination. Data will not be stored at NYIT. 
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6.3 Data and Safety Monitoring
A.
Data/Safety Monitoring Plan
The PI will monitor ongoing data collection, check actual participant files for recording accuracy, and 
monitor data entry for accuracy, including random checks throughout the duration of the study.
The research team will periodically evaluate the data collected regarding harms and benefits to 
determine whether subjects remain safe. Specifically, we will review the response to exercise (% of 
max heart rate and rate of perceived exertion) and the reports on the SSQ Cybersickness 
Questionnaires for every participant. This will be done by the study team led by the PI. At monthly 
research study meetings, we will discuss these variables. Minutes from the monthly safety minutes will 
serve to document this process.  Any follow-ups with specific participants will be added to the monthly 
documentation. Any adverse events will be reported immediately to the IRB at both Rutgers and NYIT. 
Rutgers and NYIT will have a health monitor to verify the adherence to safety. Data monitoring will be 
overseen by an independent statistician who will receive quarterly reports on data management. 
B.
Data/Safety Monitoring Board Details
Statistician (Chair)
Professor and Dean School of Public Health, Rutgers University
Health Monitor
Associate Professor and Physical Therapist, School of Health 
Professions Rutgers University, JFK Medical Center
6.4 Reporting Results
A.
Individual Subjects’ Results 
There is no plan to share individual results. 
B.
Aggregate Results
Summary of study findings will be shared with participants once published. 
C.
Professional Reporting
Study results will be disseminated at the appropriate conferences and published in the appropriate 
journals.
D.
Clinical Trials Registration, Results Reporting and Consent Posting
Study will be registered as a clinical trial upon IRB approval. 
6.5 Secondary Use of the Data   
NA
7.0 Research Repositories – Specimens and/or Data
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Data will be stored for future research: (1) are the dependent variables from the study (2) to be stored in 
Synapse.Org. 
8.0 Approvals/Authorizations
NA
9.0 Bibliography
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