Aerobic Exercise for Parkinson's Disease

(GEARS Trial)

Overseen By Anson Rosenfeldt, DPT

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Jay Alberts

Must be taking: Anti-parkinsonian

Disqualifiers: Dementia, Neurocognitive impairment, Others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The proposed multi-site, Genetics and Aerobic Exercise to Slow PD (GEARS) Trial will, for the first time, determine the interplay between genetics and exercise in altering PD progression. In sum, 200 PD patients will be recruited from the Cleveland and Salt Lake City metro areas to participate in the Pedaling for Parkinson's (PFP) community-based exercise program. Participants will exercise at community-based sites 3x/week for 12 months. All participants will undergo genotyping using an array that includes the genome backbone and common risk variants associated to increase risk for multiple neurological disorders including PD.

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 data supports the effectiveness of the treatment High intensity stationary cycling for Parkinson's Disease?

Research shows that high-intensity stationary cycling can improve symptoms in people with Parkinson's Disease. In a study, participants who cycled regularly showed better motor function and memory, and another study found improvements in fitness and brain health markers. ^{1 2 3 4 5}

Is aerobic exercise, like high-intensity stationary cycling, safe for people with Parkinson's disease?

There is no specific safety data available for aerobic exercise like high-intensity stationary cycling in Parkinson's disease from the provided research articles. ^{6 7 8 9 10}

How does high-intensity stationary cycling differ from other treatments for Parkinson's disease?

High-intensity stationary cycling, like the Pedaling for Parkinson's program, is unique because it focuses on aerobic exercise to improve motor function and potentially slow disease progression, unlike traditional treatments that primarily rely on medication. This exercise increases heart rate and cadence, which may enhance brain function and improve symptoms by increasing levels of brain-derived neurotrophic factor (BDNF), a protein that supports brain health. ^{1 5 11 12 13}

Eligibility Criteria

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

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

Exclusion Criteria

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

I have a heart rhythm problem.

I have a condition like arthritis that makes it hard for me to cycle.

Trial Timeline

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)

Treatment Details

Interventions

• High intensity stationary cycling (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England 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. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Trial Highlights - Aerobic Exercise for Parkinson's Disease. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Vastly Different Exercise Programs Similarly Improve Parkinsonian Symptoms: A Randomized Clinical Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

An 8-week aerobic cycling intervention elicits improved gait velocity and biomechanics in persons with Parkinson's disease. [2023]

5. Switzerland 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. [2020]

6. Austria pubmed.ncbi.nlm.nih.gov

An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson's disease. [2019]

7. England 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. [2016]

8. Switzerland 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. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Etiopathogenesis and treatment of Parkinson's disease. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic exercise intervention improves aerobic capacity and movement initiation in Parkinson's disease patients. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. [2011]

13. United States pubmed.ncbi.nlm.nih.gov

Repeatability of aerobic capacity measurements in Parkinson disease. [2021]