Virtual Cycling Environments for Persons With Parkinson Disease

Parkinson Disease Clinical Trial

— VCYCLE_PD  

Official title:

Virtual Cycling Environments (VCYCLE) Increases Exercise Intensity of Persons With Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04804202
• Other study ID #: Pro202000518
• Secondary ID: R15AG063348-01
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2022
• Source: Rutgers, The State University of New Jersey
• Contact: Judith Deutsch, PT, PhD
• Phone: 973-972-2373
• Email: deutsch[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	School of Health Professions	Newark	New Jersey
United States	New York Institute of Technology	Old Westbury	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	UPDRS-III Subscale	Description of Motor Performance Scored from 0-108 a lower score is better outcome	Collected once in Day 1
Other	Physical Activity Scale for the Elderly	Exercise Inventory Questionnaire	Collected once in Day 1
Other	Geriatric Depression Scale (short form)	15 item inventory to rate depression (scored from 0-15 with a lower score being better)	Collected once during Day 0 (screening)
Primary	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
Primary	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
Primary	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
Primary	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	Borg Scale for Rate of perceived exertion	Self-Report of Effort collected at a multiple time points to compare with exercise bouts	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)
Secondary	Cyber sickness Questionnaire	16 item questionnaire about feelings or symptoms of cyber sickness	Collected in Day 1 (2 hour session) twice to compare before and after scores
Secondary	Perceived Effort Ranking	Rating of Bicycling Conditions relative to each other (and audio recording of experience)	Collected in once in day 1 and once in day 2
Secondary	Enjoyment Ranking	Rating of Bicycling Conditions relative to each other (and audio recording of experience)	Collected in once in day 1 and once in day 2