Virtual Rehab Cycling for Parkinson's Disease

(PDBIKE Trial)

Overseen By Aasef G Shaikh, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Antiparkinsonian

Disqualifiers: Stroke, Atypical parkinsonism, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new virtual rehab method for people with Parkinson's disease, a condition that affects movement and causes tremors. The study compares two cycling exercises: dynamic cycling, which adapts to a person's movement ability, and forced cycling, which remains constant regardless of performance. The goal is to determine if these exercises can improve movement issues for those unable to travel easily for therapy. This trial suits individuals with Parkinson's who have maintained stable medication for six months and can perform exercises at home. As an unphased trial, it offers an opportunity to contribute to innovative research that could enhance home-based therapy options for Parkinson's patients.

Will I have to stop taking my current medications?

The trial requires that participants have a stable medical regimen of antiparkinsonian medication for at least six months, so you will not need to stop taking your current medications if they are stable.

What prior data suggests that this virtual rehab cycling technique is safe for Parkinson's disease patients?

Research shows that both dynamic cycling and forced cycling are generally safe for people with Parkinson's disease. Studies have found that cycling at a faster pace than usual can help improve symptoms like tremors and slow movement. Most participants handle these cycling exercises well.

In past studies, dynamic cycling, which adjusts to the rider's performance, led to a 35% reduction in Parkinson's symptoms for some people. This indicates it is not only effective but also manageable for participants. Significant negative side effects have not been reported, making it a promising option.

Forced cycling, where the pedaling speed remains constant, also helps improve movement symptoms. Maintaining a steady pace seems to lead to better movement outcomes. Again, no major negative effects have been reported, suggesting it is safe for participants.

Overall, current evidence supports that both cycling methods are safe and can effectively reduce symptoms in Parkinson's patients without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual rehab cycling for Parkinson's disease because it offers a unique approach compared to standard treatments, which often include medications like levodopa or therapies like deep brain stimulation. Unlike these traditional options, which primarily focus on managing symptoms, dynamic cycling adjusts its intensity based on the participant's motor performance, potentially offering a personalized exercise regimen that could improve tremors and movement speed. Forced cycling, on the other hand, maintains consistent parameters, providing a steady workout regardless of performance changes. This approach aims to enhance physical activity in a controlled, virtual environment, potentially offering new insights into how tailored exercise regimens can benefit those with Parkinson's disease.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

In this trial, participants will be assigned to one of two cycling interventions. Research has shown that dynamic cycling, one of the study arms, can improve movement problems in people with Parkinson's disease. This type of cycling adjusts to a person's movement ability, helping to reduce shaking and increase movement speed. High-cadence cycling, a component of dynamic cycling, has been found to alleviate symptoms like shaking and slow movement.

Another arm of this trial involves forced cycling, where the speed remains constant regardless of motor performance. Research also supports the benefits of forced cycling, as this method has been observed to improve movement, though the benefits may vary among individuals. Both treatments in this trial offer promising ways to enhance movement and manage Parkinson's symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Aasef G. Shaikh, MD PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who can consent, have been on stable Parkinson's medication for at least six months, and are in stages I-III of the disease without medication. It excludes those with severe cognitive impairment, depression or anxiety disorders, certain other neurological conditions, untreated cardiovascular issues, or significant fatigue or breathlessness during mild activity.

Inclusion Criteria

My Parkinson's is in the early to mid stages without medication.

My Parkinson's medication has been the same for at least 6 months.

You have been diagnosed with Parkinson's disease using the UK Brain Bank criteria.

Exclusion Criteria

I have symptoms like chest pain or shortness of breath, indicating heart issues.

I have been diagnosed with a brain injury, stroke, or a type of Parkinson's disease.

Your anxiety score is higher than 24 on the Hamilton scale.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in dynamic cycling exercise regimen, monitored and adjusted remotely, for 4 weeks

4 weeks

Remote monitoring with wearable sensors

Follow-up

Participants are monitored for changes in motor function, balance, and cognitive outcomes at 0, 3, and 6 months after the intervention

6 months

Remote assessments at 0, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic cycling
• Forced cycling

Trial Overview

The study tests a new rehab method called dynamic cycling that patients can do from home using virtual technology. This could help people who can't travel to specialized centers due to various limitations like pandemics or lack of resources.

How Is the Trial Designed?

Group I: Dynamic cycling Experimental Treatment 1 Intervention

The cycling parameters will change according to motor performance of the participants. Motor performance will be measured by assessing the change in tremor and movement speed.

Group II: Forced cycling Active Control 1 Intervention

The cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed.

Dynamic cycling is already approved in United States for the following indications:

Approved in United States as Dynamic cycling for:

• Parkinson's disease rehabilitation

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A pilot study involving 10 participants with Parkinson's disease showed that a 50-minute session of fast-paced rhythmic upper limb exercise improved their movement accuracy and speed, indicating potential benefits for motor function.

The exercise program also led to significant improvements in upper-limb motor scores, suggesting that rhythmic movements could be a feasible and beneficial intervention for patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in upper-limb UPDRS motor scores following fast-paced arm exercise: A pilot study. Levy-Tzedek, S., Arbelle, D., Forman, D., et al.[2023]

A pilot trial involving 10 individuals with Parkinson's disease demonstrated that a 40-minute session of active-assisted cycling (AAC) was well tolerated and did not cause excessive fatigue.

Most participants experienced immediate improvements in tremor and bradykinesia after the AAC session, suggesting that high-intensity cycling could be an effective intervention for enhancing motor function in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active-assisted cycling improves tremor and bradykinesia in Parkinson's disease. Ridgel, AL., Peacock, CA., Fickes, EJ., et al.[2022]

In a study involving 11 participants with severe mobility impairment due to multiple sclerosis, functional electrical stimulation (FES) cycling was found to significantly improve cardiorespiratory fitness (CRF) compared to passive leg cycling, indicating its potential as an effective exercise modality.

The FES cycling resulted in moderate-to-vigorous intensity exercise, with participants achieving 63.5% of their peak oxygen consumption and 76.4% of their peak heart rate, suggesting that it can provide a sufficient stimulus for enhancing CRF in individuals with severe MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory demand of acute voluntary cycling with functional electrical stimulation in individuals with multiple sclerosis with severe mobility impairment. Edwards, T., Motl, RW., Pilutti, LA.[2018]

Passive leg cycling significantly reduces tremor and bradykinesia in individuals with mild-to-moderate Parkinson's disease, indicating a potential therapeutic benefit for upper extremity motor function.

The rate of passive cycling (60, 70, or 80 rpm) did not influence the level of improvement in motor function, suggesting that the benefits of passive cycling may be consistent regardless of speed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. Ridgel, AL., Muller, MD., Kim, CH., et al.[2011]

Persons with Parkinson's disease (PD) and age-matched healthy adults both increased their pedaling rates while cycling in a virtual environment (VE) with auditory and visual cues, indicating that these cues can effectively enhance exercise intensity.

However, individuals with PD needed explicit instructions to focus on visual cues to increase their cycling speed, suggesting that attention to cues is crucial for this group to benefit from the exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory and visual cueing modulate cycling speed of older adults and persons with Parkinson's disease in a Virtual Cycling (V-Cycle) system. Gallagher, R., Damodaran, H., Werner, WG., et al.[2018]

Dynamic cycling at a high cadence (75-85 rpm) significantly improved motor function in individuals with Parkinson's disease, showing a 13.9% improvement in UPDRS scores and a 16.5% improvement in Timed Up and Go (TUG) times after just three sessions.

In contrast, static cycling resulted in only minor improvements (0.9% in UPDRS scores and 8% in TUG times), suggesting that the high cadence and dynamic nature of cycling are crucial for enhancing motor function in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic High-Cadence Cycling Improves Motor Symptoms in Parkinson's Disease. Ridgel, AL., Phillips, RS., Walter, BL., et al.[2022]

Low cadence cycling (20 RPM) resulted in greater torque and improved bone health indicators, such as decreased bone turnover markers, compared to high cadence cycling (50 RPM) in individuals with spinal cord injury, suggesting it may be more beneficial for musculoskeletal health.

Both cycling methods increased muscle volume, but low cadence cycling showed potential for better trabecular bone microarchitecture, indicating it could help reduce fracture risk in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. Johnston, TE., Marino, RJ., Oleson, CV., et al.[2018]

This study will assess whether pedalling on a modified exercise bike can enhance recovery in stroke survivors who are within 30 days post-stroke and have unilateral weakness, involving 24 participants in a randomized controlled trial.

The primary outcome will measure the ability to voluntarily contract affected lower limb muscles, which could provide insights into the effectiveness of early pedalling exercise as a rehabilitation strategy after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: study protocol for a pilot randomised controlled trial. Hancock, NJ., Shepstone, L., Rowe, P., et al.[2021]

A new stimulation pattern for functional electrical stimulation (FES) cycling was developed, which improved muscle control and efficiency in producing forward torque, leading to better cadence tracking in both able-bodied individuals and a subject with Parkinson's disease.

Experimental results showed that the new controller achieved low cadence tracking errors of 5.27 ± 2.14 revolutions per minute during FES-induced cycling in able-bodied subjects and even lower errors in a Parkinson's disease subject, indicating its potential effectiveness for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switched Control of Cadence During Stationary Cycling Induced by Functional Electrical Stimulation. Bellman, MJ., Cheng, TH., Downey, RJ., et al.[2017]

The study found that corticospinal excitability to the biceps brachii muscle remains unchanged whether participants cycle at a self-selected cadence or a fixed cadence, indicating that the cycling speed does not affect motor cortex activity.

Using transcranial magnetic stimulation (TMS) to measure motor evoked potentials (MEPs) in both conditions showed no significant differences, suggesting that the brain's control over muscle activation is consistent regardless of cycling pace.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticospinal Excitability to the Biceps Brachii is Not Different When Arm Cycling at a Self-Selected or Fixed Cadence. Lockyer, EJ., Nippard, AP., Kean, K., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

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These findings show that dynamic cycling can improve PD motor function and that activation of proprioceptors with a high cadence but variable pattern may be ...

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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 ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1388245725004341

Electrophysiological correlates of dynamic cycling in ...

Physical exercise like dynamic cycling has shown promise in enhancing motor function in Parkinson's disease (PD). We examined the underlying mechanisms of ...

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Body Mass Index and Exercise Effort Influences Changes ...

High-cadence dynamic cycling improves motor symptoms of Parkinson's disease (PD), such as tremor and bradykinesia. However, some participants experience ...

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For example, outcomes such as strength, step length, aerobic capacity, and rigidity were grouped as measures of BFS eliminating the term motor symptoms.

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Biomechanical analysis of patients with mild Parkinson's ...

This study aims to identify the biomechanical adaptations in cycling balance control employed by individuals with PD and how they differ from those of healthy ...