Virtual Cycling Environments for Persons With Parkinson Disease

NCT04804202 | Recruiting DMC

• 2 other identifiers: Pro202000518R15AG063348-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Parkinson Disease

Keywords

virtual reality; exercise; cardiovascular intensity; neuromuscular intensity; enjoyment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Borg Scale for Rate of perceived exertion

  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

  Collected in Day 1 (2 hour session) twice to compare before and after scores

• Perceived Effort Ranking

  Collected in once in day 1 and once in day 2

• Enjoyment Ranking

  Collected in once in day 1 and once in day 2

Other Outcomes (3)

• UPDRS-III Subscale

  Collected once in Day 1

• Physical Activity Scale for the Elderly

  Collected once in Day 1

• Geriatric Depression Scale (short form)

  Collected once during Day 0 (screening)

Study Arms (1)

Virtual Reality

OTHER

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

Interventions

Bicycling with and without virtual reality OTHER

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.

Virtual Reality

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease
• Hoehn and Yahr stages II-III,
• years old
• able to ride a stationary upright bicycle
• able to sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Aging (NIA): collaborator
• New York Institute of Technology: collaborator

Study Sites (2)

School of Health Professions

Newark, New Jersey, 07011, United States

RECRUITING

New York Institute of Technology

Old Westbury, New York, 11568, United States

COMPLETED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Judith E. Deutsch, PT PhD

  Rutgers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Deutsch, PT, PhD

CONTACT

973-972-2373; deutsch@rutgers.edu

Sharon McFarlane

CONTACT

9739720281; mcfarlsb@research.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Repeated Measures Design

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 18, 2021
• Study Start: February 8, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We will make study data available immediately following completion.
• Access Criteria: Open Access

Locations

US (2)