Virtual Cycling for Parkinson's Disease

(VCYCLE_PD Trial)

Overseen By Sharon McFarlane

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality might alter the biking experience for people with Parkinson's disease. Researchers aim to determine if virtual reality increases the intensity or enjoyment of biking and how different biking styles, such as interval versus continuous, affect this experience. They are also comparing virtual reality delivered through goggles versus a screen. Suitable participants have Parkinson's disease, can ride a stationary bike, and do not have severe heart or lung issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance exercise experiences for those with Parkinson's.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that virtual cycling environments are safe for persons with Parkinson's disease?

Research shows that virtual cycling environments are generally safe for people with Parkinson's disease. One study found that using virtual reality (VR) for tandem cycling improved movement and reduced tiredness without major side effects. Another review showed that VR-based exercises helped improve balance in patients with Parkinson's and were well-tolerated.

These studies suggest that VR in cycling exercises is safe and well-accepted. No significant negative effects were reported, indicating that this treatment is safe for participants. Therefore, those considering joining a trial involving virtual cycling environments can rely on the available evidence supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Parkinson’s disease, which often involve medication or physical therapy, virtual cycling environments offer a unique, immersive experience that can enhance motor function and engagement. Researchers are excited because this approach uses virtual reality to simulate cycling, which may improve coordination and balance in a safe and controlled setting. Additionally, virtual environments can be customized to individual needs, potentially increasing motivation and adherence to exercise, which are crucial for managing Parkinson’s symptoms.

What evidence suggests that virtual cycling environments are effective for Parkinson's Disease?

Research shows that virtual cycling can help people with Parkinson's disease. One study found that using virtual reality while cycling improved movement, reduced tiredness, and boosted social interaction for participants. Other research suggests that virtual reality exercises can enhance balance in people with Parkinson's. Additionally, cycling at a fast pace, known as high-cadence cycling, has improved movement symptoms in some individuals with Parkinson's. Overall, these findings suggest that virtual cycling might make exercise more effective and enjoyable for those with Parkinson's disease. In this trial, all participants will engage in virtual cycling environments to explore these potential benefits. ^{1 2 4 6 7}

Who Is on the Research Team?

Judith E. Deutsch, PT PhD

Principal Investigator

Rutgers

Are You a Good Fit for This Trial?

This trial is for people aged 45-75 with Parkinson's Disease at stages II-III who can ride a stationary bike and sign consent. Excluded are those with vision/hearing issues, severe heart/lung disease, uncontrolled diabetes, recent brain injury or surgery, moderate depression, or any condition preventing safe cycling.

Inclusion Criteria

My Parkinson's disease is at a moderate stage.

I can ride a stationary bike.

I am between 45 and 75 years old.

Exclusion Criteria

I have been diagnosed with moderate depression.

I don't have any health issues that would stop me from riding a bicycle.

I have a health issue that stops me from riding a bike.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Session 1

Participants complete movement assessments and questionnaires, and bicycle in semi-immersive and immersive virtual environments

1 day

1 visit (in-person)

Session 2

Participants bicycle four times with and without a virtual environment using both continuous and interval modes, with oxygen consumption measured

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the sessions

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Cycling Environments

Trial Overview The study tests if virtual reality enhances the biking experience for Parkinson's patients in terms of enjoyment and exercise intensity. It compares continuous to interval biking and examines different VR delivery methods (goggles vs screen projection).

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

New York Institute of Technology

Collaborator

Trials

56

Recruited

2,300+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11263444/

The Feasibility and Efficacy of a Virtual Reality Tandem ... Dyadic VR tandem cycling significantly improved PwPD clinical disease burden, in addition to self-reported mobility, fatigue, and social ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04804202

Virtual Cycling Environments for Persons With Parkinson ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1413355524001254

117 virtual reality training compared to stationary cycling ... This study aims to evaluate the effectiveness of immersive virtual reality training, through exergames from Quest 2 device, compared to ASC training.

4. davisphinneyfoundation.org davisphinneyfoundation.org/blog/research-update-smart-cycling-and-parkinsons/

Research Update: SMART Cycling and Parkinson's The study's chief finding is that high-cadence dynamic cycling improves motor symptoms of Parkinson's but that some participants benefited more ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01219-3

A systematic review and meta-analysis on the effect of virtual ... This study's findings suggest that VR-based rehabilitation is a promising intervention for improving balance function in patients for PD compared with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10360300/

A systematic review and meta-analysis on the effect of ... This study's findings suggest that VR-based rehabilitation is a promising intervention for improving balance function in patients for PD compared with ...

7. mdpi.com mdpi.com/2076-3417/14/11/4708

Immersive Virtual Reality High-Intensity Aerobic Training to ... Intense exercise can be neuromodulatory and neuroprotective against Parkinson's disease (PD). Indoor cycling is a good and safe option for ...