VCYCLE_PD: Virtual Cycling Environments for Persons With Parkinson Disease

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT04804202
Collaborator
National Institute on Aging (NIA) (NIH), New York Institute of Technology (Other)
60
2
1
18.7
30
1.6

Study Details

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Bicycling with and without virtual reality
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Repeated Measures DesignRepeated Measures Design
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Virtual Cycling Environments (VCYCLE) Increases Exercise Intensity of Persons With Parkinson Disease
Actual Study Start Date :
Feb 8, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Neuromuscular Intensity [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]

    bicycling cadence collected continuously

  2. Physiological Responses to Exercise- Oxygen Consumption [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]

    Metabolic equivalents derived from oxygen consumption which is collected continuously during four exercise bouts.

  3. Enjoyment-Motivation [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]

    Intrinsic Motivation Inventory Enjoyment sub-scales collected at the end of each exercise bout

  4. Heart Rate % of maximum [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]

    Collected continuously during exercise bouts and will be evaluated as a % of age adjusted maximum heart rate

Secondary Outcome Measures

  1. 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)]

    Self-Report of Effort collected at a multiple time points to compare with exercise bouts

  2. Cyber sickness Questionnaire [Collected in Day 1 (2 hour session) twice to compare before and after scores]

    16 item questionnaire about feelings or symptoms of cyber sickness

  3. Perceived Effort Ranking [Collected in once in day 1 and once in day 2]

    Rating of Bicycling Conditions relative to each other (and audio recording of experience)

  4. Enjoyment Ranking [Collected in once in day 1 and once in day 2]

    Rating of Bicycling Conditions relative to each other (and audio recording of experience)

Other Outcome Measures

  1. UPDRS-III Subscale [Collected once in Day 1]

    Description of Motor Performance Scored from 0-108 a lower score is better outcome

  2. Physical Activity Scale for the Elderly [Collected once in Day 1]

    Exercise Inventory Questionnaire

  3. Geriatric Depression Scale (short form) [Collected once during Day 0 (screening)]

    15 item inventory to rate depression (scored from 0-15 with a lower score being better)

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Health Professions Newark New Jersey United States 07011
2 New York Institute of Technology Old Westbury New York United States 11568

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Judith E. Deutsch, PT PhD, Rutgers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judith E Deutsch, PT, PhD, Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT04804202
Other Study ID Numbers:
  • Pro202000518
  • R15AG063348-01
First Posted:
Mar 18, 2021
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Judith E Deutsch, PT, PhD, Professor, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021