search
Back to results

Virtual Cycling Environments for Persons With Parkinson Disease (VCYCLE_PD)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bicycling with and without virtual reality
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring virtual reality, exercise, cardiovascular intensity, neuromuscular intensity, enjoyment

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Health ProfessionsRecruiting
  • New York Institute of TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Virtual Reality

Arm Description

This is a single arm study in which all participants will execute the same tasks over two sessions.

Outcomes

Primary Outcome Measures

Neuromuscular Intensity
bicycling cadence collected continuously
Physiological Responses to Exercise- Oxygen Consumption
Metabolic equivalents derived from oxygen consumption which is collected continuously during four exercise bouts.
Enjoyment-Motivation
Intrinsic Motivation Inventory Enjoyment sub-scales collected at the end of each exercise bout
Heart Rate % of maximum
Collected continuously during exercise bouts and will be evaluated as a % of age adjusted maximum heart rate

Secondary Outcome Measures

Borg Scale for Rate of perceived exertion
Self-Report of Effort collected at a multiple time points to compare with exercise bouts
Cyber sickness Questionnaire
16 item questionnaire about feelings or symptoms of cyber sickness
Perceived Effort Ranking
Rating of Bicycling Conditions relative to each other (and audio recording of experience)
Enjoyment Ranking
Rating of Bicycling Conditions relative to each other (and audio recording of experience)

Full Information

First Posted
March 2, 2021
Last Updated
June 24, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Aging (NIA), New York Institute of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT04804202
Brief Title
Virtual Cycling Environments for Persons With Parkinson Disease
Acronym
VCYCLE_PD
Official Title
Virtual Cycling Environments (VCYCLE) Increases Exercise Intensity of Persons With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Aging (NIA), New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
virtual reality, exercise, cardiovascular intensity, neuromuscular intensity, enjoyment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated Measures Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Other
Arm Description
This is a single arm study in which all participants will execute the same tasks over two sessions.
Intervention Type
Other
Intervention Name(s)
Bicycling with and without virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuromuscular Intensity
Description
bicycling cadence collected continuously
Time Frame
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
Title
Physiological Responses to Exercise- Oxygen Consumption
Description
Metabolic equivalents derived from oxygen consumption which is collected continuously during four exercise bouts.
Time Frame
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
Title
Enjoyment-Motivation
Description
Intrinsic Motivation Inventory Enjoyment sub-scales collected at the end of each exercise bout
Time Frame
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
Title
Heart Rate % of maximum
Description
Collected continuously during exercise bouts and will be evaluated as a % of age adjusted maximum heart rate
Time Frame
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 Measure Information:
Title
Borg Scale for Rate of perceived exertion
Description
Self-Report of Effort collected at a multiple time points to compare with exercise bouts
Time Frame
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)
Title
Cyber sickness Questionnaire
Description
16 item questionnaire about feelings or symptoms of cyber sickness
Time Frame
Collected in Day 1 (2 hour session) twice to compare before and after scores
Title
Perceived Effort Ranking
Description
Rating of Bicycling Conditions relative to each other (and audio recording of experience)
Time Frame
Collected in once in day 1 and once in day 2
Title
Enjoyment Ranking
Description
Rating of Bicycling Conditions relative to each other (and audio recording of experience)
Time Frame
Collected in once in day 1 and once in day 2
Other Pre-specified Outcome Measures:
Title
UPDRS-III Subscale
Description
Description of Motor Performance Scored from 0-108 a lower score is better outcome
Time Frame
Collected once in Day 1
Title
Physical Activity Scale for the Elderly
Description
Exercise Inventory Questionnaire
Time Frame
Collected once in Day 1
Title
Geriatric Depression Scale (short form)
Description
15 item inventory to rate depression (scored from 0-15 with a lower score being better)
Time Frame
Collected once during Day 0 (screening)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinson's disease Hoehn and Yahr stages II-III, 45-75 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Deutsch, PT, PhD
Phone
973-972-2373
Email
deutsch@rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon McFarlane
Phone
9739720281
Email
mcfarlsb@research.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith E. Deutsch, PT PhD
Organizational Affiliation
Rutgers
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Professions
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith E. Deutsch
Phone
973-972-2373
Email
deutsch@rutgers.edu
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosemary Gallagher, PT, PhD
Email
rgalla01@nyit.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Virtual Cycling Environments for Persons With Parkinson Disease

We'll reach out to this number within 24 hrs