Clinical trial NCT04804202: Virtual Cycling Environments for Persons With Parkinson Disease
Official title: Virtual Cycling Environments (VCYCLE) Increases Exercise Intensity of Persons With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: virtual reality
exercise
cardiovascular intensity
neuromuscular intensity
enjoyment
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: New York Institute of Technology
First posted: 2021-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated Measures Design
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Neuromuscular Intensity
timeFrame: 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
measure: Physiological Responses to Exercise- Oxygen Consumption
timeFrame: 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
measure: Enjoyment-Motivation
timeFrame: 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
measure: Heart Rate % of maximum
timeFrame: 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:
measure: Borg Scale for Rate of perceived exertion
timeFrame: 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)
measure: Cyber sickness Questionnaire
timeFrame: Collected in Day 1 (2 hour session) twice to compare before and after scores
measure: Perceived Effort Ranking
timeFrame: Collected in once in day 1 and once in day 2
measure: Enjoyment Ranking
timeFrame: Collected in once in day 1 and once in day 2
Other outcomes:
measure: UPDRS-III Subscale
timeFrame: Collected once in Day 1
measure: Physical Activity Scale for the Elderly
timeFrame: Collected once in Day 1
measure: Geriatric Depression Scale (short form)
timeFrame: Collected once during Day 0 (screening)
Locations:
city: Newark
country: United States
facility: School of Health Professions
state: New Jersey
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: Rutgers
name: Judith E. Deutsch, PT PhD
role: PRINCIPAL_INVESTIGATOR
References: