Virtual Cycling Environments for Persons With Parkinson Disease (VCYCLE_PD)

Virtual Cycling Environments (VCYCLE) Increases Exercise Intensity of Persons With Parkinson Disease

This study asks three questions about Persons with Parkinson Disease that use a bicycle for exercise. 1. Does the use of virtual reality increase the intensity and and enjoyment of the experience compared to bicycling without virtual reality? 2. Does the way in which the bicycling (interval compared to continous) is performed affect the experience? 3. How does the way the virtual reality is delivered (with goggles or projected on a screen) affect the experience?

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Bicycling with and without virtual reality

Detailed Description

Participants attend two sessions. They complete movement assessments and questionnaires about physical activity. During the first session they bicycle in a semi-immersive (projected on a screen) and an immersive (with googles) virtual environment. After each bout they completed a questionnaire about the experience. In the second session they bicycle four times with and without a virtual environment using both a continous and interval mode. Their oxygen consumption is measured during cycling. They complete questionnaires after each exercise bout.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judith Deutsch, PT, PhD; Phone Number: 973-972-2373; Email: deutsch@rutgers.edu
• Study Contact Backup: Name: Sharon McFarlane; Phone Number: 9739720281; Email: mcfarlsb@research.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07011
      • Recruiting
      • School of Health Professions
      • Contact: Judith E. Deutsch; Phone Number: 9739722373; Email: deutsch@rutgers.edu
  • New York
    • Old Westbury, New York, United States, 11568
      • Completed
      • New York Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Hoehn and Yahr stages II-III,
3. 45-75 years old
4. able to ride a stationary upright bicycle
5. able to sign informed consent.

Exclusion Criteria:

1. Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than Parkinson Disease.
2. Are unable to follow directions or sign a consent form
3. Do not have adequate vision or hearing ability to see or hear a television
4. 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
5. Have any other medical condition that prevents bicycling
6. Have moderate depression

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; This is a single arm study in which all participants will execute the same tasks over two sessions.	Other: Bicycling with and without virtual reality; In one session: Exercise intensity and enjoyment are measured while participants bicycle in a virtual compared to non-virtual environment. Cycling takes places in two modes continous and interval. In a second session exercise intensity and enjoyment are compared during bicycling with virtual reality presented in two different ways.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular Intensity	bicycling cadence collected continuously	Collected in two sessions: Session 1(day 1 for 2 hours) collected continuously during 2 exercise bouts to compare exercise bouts.____Session 2 (day 2 for 2 hours) collected continuously in four exercise bouts to compare exercise bouts
Physiological Responses to Exercise- Oxygen Consumption	Metabolic equivalents derived from oxygen consumption which is collected continuously during four exercise bouts.	Collected in two sessions: Session 1(day 1 for 2 hours) collected continuously during 2 exercise bouts to compare exercise bouts___ Session 2 (day 2 for 2 hours) collected continuously in four exercise bouts to compare exercise bouts
Enjoyment-Motivation	Intrinsic Motivation Inventory Enjoyment sub-scales collected at the end of each exercise bout	Collected in two sessions: Session 1 collected continuously during 2 exercise bouts in a 2 hour Session 2: in four exercise bouts in a 2 hour session to compare exercise bouts
Heart Rate % of maximum	Collected continuously during exercise bouts and will be evaluated as a % of age adjusted maximum heart rate	Collected in two sessions: Session 1 collected continuously during 2 exercise bouts in a 2 hour Session 2: in four exercise bouts in a 2 hour session to compare exercise bouts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg Scale for Rate of perceived exertion	Self-Report of Effort collected at a multiple time points to compare with exercise bouts	Collected in both Day 1 and 2 (each day is two hours) as follows: Day 1 (4 times in each of the two cycling bouts) Day 2 (6 times each of the four cycling bouts)
Cyber sickness Questionnaire	16 item questionnaire about feelings or symptoms of cyber sickness	Collected in Day 1 (2 hour session) twice to compare before and after scores
Perceived Effort Ranking	Rating of Bicycling Conditions relative to each other (and audio recording of experience)	Collected in once in day 1 and once in day 2
Enjoyment Ranking	Rating of Bicycling Conditions relative to each other (and audio recording of experience)	Collected in once in day 1 and once in day 2

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 in Day 1
Physical Activity Scale for the Elderly	Exercise Inventory Questionnaire	Collected once in Day 1
Geriatric Depression Scale (short form)	15 item inventory to rate depression (scored from 0-15 with a lower score being better)	Collected once during Day 0 (screening)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Aging (NIA); New York Institute of Technology
• Investigators: Principal Investigator: Judith E. Deutsch, PT PhD, Rutgers

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: exercise; virtual reality; enjoyment; cardiovascular intensity; neuromuscular intensity
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: Pro202000518; R15AG063348-01 (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 our proposed study we will submit a de-identified data set of our protocol and links to published papers.
• IPD Sharing Time Frame: We 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
• product manufactured in and exported from the U.S.: No