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Virtual Cycling Environments for Persons With Parkinson Disease (VCYCLE_PD)

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ClinicalTrials.gov Identifier: NCT04804202
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Collaborators:
National Institute on Aging (NIA)
New York Institute of Technology
Information provided by (Responsible Party):
Judith E Deutsch, PT, PhD, Rutgers, The State University of New Jersey

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
Parkinson Disease Other: Bicycling with and without virtual reality Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated 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 : February 8, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Neuromuscular Intensity [ 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 ]
    bicycling cadence collected continuously

  2. Physiological Responses to Exercise- Oxygen Consumption [ 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 ]
    Metabolic equivalents derived from oxygen consumption which is collected continuously during four exercise bouts.

  3. Enjoyment-Motivation [ 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 ]
    Intrinsic Motivation Inventory Enjoyment sub-scales collected at the end of each exercise bout

  4. Heart Rate % of maximum [ 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 ]
    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 [ 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) ]
    Self-Report of Effort collected at a multiple time points to compare with exercise bouts

  2. Cyber sickness Questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Collected once in Day 1 ]
    Exercise Inventory Questionnaire

  3. Geriatric Depression Scale (short form) [ Time Frame: Collected once during Day 0 (screening) ]
    15 item inventory to rate depression (scored from 0-15 with a lower score being better)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804202


Contacts
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Contact: Judith Deutsch, PT, PhD 973-972-2373 deutsch@rutgers.edu
Contact: Sharon McFarlane 9739720281 mcfarlsb@research.rutgers.edu

Locations
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United States, New Jersey
School of Health Professions Recruiting
Newark, New Jersey, United States, 07011
Contact: Judith E. Deutsch    973-972-2373    deutsch@rutgers.edu   
United States, New York
New York Institute of Technology Recruiting
Old Westbury, New York, United States, 11568
Contact: Rosemary Gallagher, PT, PhD       rgalla01@nyit.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute on Aging (NIA)
New York Institute of Technology
Investigators
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Principal Investigator: Judith E. Deutsch, PT PhD Rutgers
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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 ( U.S. NIH Grant/Contract )
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: We will make study data available immediately following completion.
Access Criteria: Open Access

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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, Rutgers, The State University of New Jersey:
virtual reality
exercise
cardiovascular intensity
neuromuscular intensity
enjoyment
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases