Aerobic Exercise for Parkinson's Disease

(GEARS Trial)

Overseen By Anson Rosenfeldt, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jay Alberts

Must be taking: Anti-parkinsonian

Disqualifiers: Dementia, Neurocognitive impairment, Others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how genetics and exercise together might affect the progression of Parkinson's disease. Participants will engage in high-intensity stationary cycling, known as Pedaling for Parkinson's (PFP), three times a week for a year. The goal is to determine if this routine can slow the disease's effects. Suitable candidates include those diagnosed with Parkinson's who can safely ride a stationary bike and have reliable transportation to the exercise site. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new insights and potential treatments for Parkinson's disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are on a stable dose of anti-parkinsonian medication. This suggests you may continue your current medication regimen.

What prior data suggests that high intensity stationary cycling is safe for Parkinson's disease patients?

Research has shown that high-intensity stationary cycling is generally safe for people with Parkinson's disease (PD). Studies suggest this exercise is an affordable and effective way to manage PD symptoms. Those who regularly engage in high-speed cycling often experience fewer symptoms and more good days.

High-intensity cycling may help the brain adapt and improve movement skills, such as walking. One study found that regular high-intensity exercise could protect brain cells that produce dopamine, which is crucial for controlling movement.

These studies suggest that people with PD tolerate high-intensity cycling well. No major negative side effects have been reported, making this exercise a promising option for safely managing PD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity stationary cycling for Parkinson's disease because it offers a non-drug approach that could complement existing treatments like medication and deep brain stimulation. Unlike typical treatments that focus on managing symptoms through chemical or surgical means, this method uses aerobic exercise to potentially improve overall motor function and quality of life. The community-based exercise setting also offers a social and supportive environment, which can be beneficial for mental and emotional well-being.

What evidence suggests that high intensity stationary cycling is effective for Parkinson's Disease?

Research has shown that high-intensity stationary cycling can slow the worsening of movement problems in people with Parkinson's disease. One study found that participants who followed a cycling routine experienced a much slower progression of movement issues after a year. Another study demonstrated that cycling in a community setting improved symptoms over six months. Specifically, participants in the Pedaling for Parkinson's program experienced up to a 35% improvement in their symptoms after cycling three times a week for eight weeks. In this trial, all participants will engage in high-intensity stationary cycling in a community setting three times a week for 12 months. Overall, cycling appears to improve movement abilities in people with Parkinson's disease. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with Parkinson's Disease (PD) stages I-III who can safely use a stationary bike, have reliable transport to the exercise facility, and own a smartphone for monitoring activity. They must be on stable PD medication.

Inclusion Criteria

My Parkinson's disease is in the early to mid-stage.

I have been diagnosed with Parkinson's disease by a healthcare professional.

I am on a consistent dose of Parkinson's disease medication.

Exclusion Criteria

I have a neurological condition that is not Parkinson's disease.

I have a heart rhythm problem.

Participation in disease modifying PD-related clinical trial or study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants undergo genotyping and baseline assessments, including informed consent and medication reconciliation

2 weeks

2 visits (in-person)

Treatment

Participants engage in a community-based exercise program 3 times per week for 12 months

12 months

3 visits per week (community-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High intensity stationary cycling

Trial Overview

The trial is testing if high-intensity cycling 3 times a week at community sites can slow down PD progression. It also examines how genetics might influence this effect. Participants will cycle for one year and undergo genetic testing.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

All participants will exercise in a community setting 3x/week for 12 months

Who Is Running the Clinical Trial?

Jay Alberts

Lead Sponsor

Trials

3

Recruited

220+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

An 8-week aerobic cycling intervention significantly improved comfortable gait velocity in individuals with mild to moderate Parkinson's disease, increasing from 0.86 m/s to 1.00 m/s, while the control group experienced a decline in gait speed.

Improvements in gait velocity were accompanied by enhancements in gait biomechanics, indicating that aerobic cycling not only boosts walking speed but also normalizes gait patterns, making it a promising treatment for mobility issues in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An 8-week aerobic cycling intervention elicits improved gait velocity and biomechanics in persons with Parkinson's disease. Linder, SM., Baron, E., Learman, K., et al.[2023]

In a long-term study involving 419 participants with early and advanced Parkinson's disease, ropinirole extended release was found to be safe, with no new or unexpected safety concerns over a median exposure of 1275 days.

Most participants (87%) experienced at least one adverse event, with common issues including back pain and hallucinations, but a majority preferred the once-daily dosing regimen over more frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Makumi, CW., Asgharian, A., Ellis, J., et al.[2016]

A 16-week high-intensity tandem bicycle program significantly improved VO2max and motor function in 13 patients with Parkinson's Disease, while the control group showed a decline in these measures.

The exercise program also led to a more than 10-fold increase in plasma brain-derived neurotrophic factor (BDNF) levels, which correlated with improved motor function, suggesting a potential mechanism for the benefits of exercise in PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a High-Intensity Tandem Bicycle Exercise Program on Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers in Parkinson's Disease. Segura, C., Eraso, M., Bonilla, J., et al.[2020]

Aerobic exercise may positively affect motor symptoms in Parkinson's disease and could potentially slow its progression, as suggested by ongoing randomized clinical trials (RCTs).

The review identified six RCTs with participant numbers ranging from 28 to 370 and follow-up periods between 8 weeks and 18 months, highlighting the need for more studies that explore both clinical outcomes and neuroplasticity markers to determine the best exercise parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trial Highlights - Aerobic Exercise for Parkinson's Disease. Schootemeijer, S., Darweesh, SKL., de Vries, NM.[2023]

A Bayesian network meta-analysis of 20 randomized controlled trials involving 6,560 patients found that apomorphine was the most effective dopamine agonist for increasing 'ON' time without troublesome dyskinesia in advanced Parkinson's disease patients.

The analysis also indicated that adding pramipexole, ropinirole, or rotigotine to levodopa treatment improved motor function and had an acceptable safety profile, making them viable options for managing motor fluctuations in advanced PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials. Ruan, X., Lin, F., Wu, D., et al.[2021]

Parkinson's disease involves complex mechanisms of neurodegeneration, including oxidative stress and mitochondrial dysfunction, which present multiple potential targets for new treatments, such as bioenergetic agents and neurotrophic factors.

Current dopaminergic therapies may have disease-modifying effects, as studies suggest that significant dopaminergic neuron loss occurs before motor symptoms appear, highlighting the importance of early intervention in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etiopathogenesis and treatment of Parkinson's disease. Gallagher, DA., Schapira, AH.[2018]

Apomorphine (Apokyn) is an effective rescue treatment for 'off' episodes in patients with advanced Parkinson's disease, administered through subcutaneous injection.

While it is effective, apomorphine can cause side effects such as nausea, vomiting, and drowsiness, so it is recommended to take it with an antiemetic to minimize nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apomorphine (Apokyn) for advanced Parkinson's Disease. [2013]

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]

A 16-week aerobic exercise program for 8 Parkinson's Disease patients led to a significant 26% improvement in aerobic capacity, indicating that exercise can benefit PD patients similarly to healthy individuals.

The intervention also resulted in faster movement initiation times, suggesting that aerobic exercise may help counteract the slowing of muscle activation associated with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise intervention improves aerobic capacity and movement initiation in Parkinson's disease patients. Bergen, JL., Toole, T., Elliott, RG., et al.[2022]

The study found that measuring peak aerobic capacity (VO2peak) is reliable in individuals with mild to moderate Parkinson's disease, with high intraclass correlation coefficients (ICC) of 0.90 and 0.94, indicating consistent results across multiple tests.

This reliability supports the use of VO2peak as a valid outcome measure for assessing the impact of exercise interventions on cardiorespiratory fitness in people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability of aerobic capacity measurements in Parkinson disease. Katzel, LI., Sorkin, JD., Macko, RF., et al.[2021]

In a 6-month community-based cycling program for 41 participants with Parkinson's disease, significant improvements were observed in motor function, as indicated by a decrease in the MDS-UPDRS-III score, suggesting that aerobic exercise can help slow disease progression.

Participants who attended at least 74% of the cycling classes experienced the greatest benefits, highlighting the importance of consistent exercise attendance and maintaining a higher pedaling cadence for mitigating Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based high-intensity cycling improves disease symptoms in individuals with Parkinson's disease: A six-month pragmatic observational study. Rosenfeldt, AB., Miller Koop, M., Penko, AL., et al.[2023]

In a study involving 74 nondemented Parkinson's disease patients, both agility exergaming and stationary cycling exercises led to significant improvements in mobility and clinical symptoms, as measured by the UPDRS-II scale, with agility exergaming showing slightly greater benefits in activities of daily living and balance.

Both exercise interventions were effective, but there were no significant differences between the two methods in most outcomes, suggesting that different types of exercise can be beneficial for managing Parkinson's disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vastly Different Exercise Programs Similarly Improve Parkinsonian Symptoms: A Randomized Clinical Trial. Tollár, J., Nagy, F., Hortobágyi, T.[2019]

In a real-world study involving 1531 patients with Parkinson's disease, dopamine-substituting therapies, including rotigotine, showed significant improvements in motor scores over a follow-up period of up to 33 months.

The study found that the safety profile of these therapies was consistent with expectations, with rare instances of cardiovalvular pathology that were not causally linked to rotigotine, indicating its long-term safety in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson's disease. Müller, T., Tolosa, E., Badea, L., et al.[2019]

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Those prescribed the cycling regimen demonstrated a significantly lower rate of motor symptom progression at 12 months than those receiving ...

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pmc.ncbi.nlm.nih.gov/articles/PMC10092122/

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Participants who ride three days a week over eight weeks have shown improvement in their Parkinson's-related symptoms by as much as 35%. Classes usually meet on ...

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Dynamic High-Cadence Cycling Improves Motor Symptoms in ...

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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nature.com

nature.com/articles/s41531-021-00222-6

Parkinson's disease patients benefit from bicycling

Outcomes measuring motor parameters improved more from bicycling intervention when compared to the outcomes assessing cognitive performance.

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pmc.ncbi.nlm.nih.gov/articles/PMC4744893/

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7642485/

High-Intensity Interval Cycle Ergometer Training in ...

Recent studies suggest that high-intensity interval training (HIIT) is promising for promoting neuroplasticity in human PD, with short training time and reduced ...

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medicine.yale.edu/news-article/high-intensity-exercise-can-reverse-neurodegeneration-in-parkinsons-disease/

High-intensity Exercise May Reverse Neurodegeneration in ...

Six months of high-intensity aerobic exercise preserves the dopamine-producing neurons in the brain, a small pilot study finds.