Exercise for Parkinson's Disease

Overseen By Elizabeth Jansen, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Dementia, Neurocognitive impairment, Musculoskeletal issues, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of exercise—forced and voluntary—affect people with Parkinson's Disease (PD) who use the Medtronic Percept PC DBS device. Researchers aim to determine the impact of a single 150-minute session of high-intensity exercise on participants when their usual PD treatments are paused. Suitable candidates have been diagnosed with PD, have used the Medtronic DBS device for at least six months, and can safely use an exercise bike. Participants must be able to pause their Parkinson's medication and device for the trial duration. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future PD treatment strategies.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your antiparkinsonian medication and turn off your DBS (deep brain stimulation) during the trial session.

What prior data suggests that this exercise protocol is safe for Parkinson's Disease patients?

Research has shown that high-intensity exercise is generally safe for people with Parkinson's disease. One study found that exercise levels of 80% to 85% and 60% to 65% were safe and feasible for participants. Another study discovered that assisted exercise, rather than independent exercise, improved movement in people with Parkinson's. This suggests that the exercises in this clinical trial are likely to be well-tolerated. While safety remains a priority, existing evidence supports the safety of these types of exercise for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment for Parkinson's disease because it offers a non-pharmaceutical approach that could complement or enhance existing therapies like medication and surgery. Unlike standard treatments, which often focus on managing symptoms through drugs like levodopa, the exercise program emphasizes neuroplasticity and the potential for exercise to improve motor function and overall quality of life. This approach is particularly promising because it harnesses the body's natural ability to adapt, which might lead to fewer side effects and a more holistic improvement in patient health.

What evidence suggests that forced and voluntary exercise might be effective for Parkinson's Disease?

This trial will evaluate two modes of high-intensity exercise for people with Parkinson's Disease (PD). Studies have shown that both forced and voluntary exercise can benefit individuals with PD. Research suggests that intense exercise might even reverse some brain changes caused by PD. Specifically, previous studies demonstrated that forced exercise improves communication between the brain and muscles, which is crucial for better movement and balance. A review of studies found that aerobic exercise aids balance, walking speed, and overall movement. These findings suggest that exercise could be a powerful way to manage PD symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Jay Alberts, Ph.D.

Principal Investigator

Staff

Are You a Good Fit for This Trial?

This trial is for adults with Parkinson's Disease (PD) who have had a Medtronic Percept PC DBS system in place for at least six months and stable settings for three. Participants must be able to stop PD medications and DBS, pass an exercise safety screening or get doctor clearance, and safely use a recumbent cycle.

Inclusion Criteria

My deep brain stimulation settings have been stable for 3 months.

I have had Medtronic Precept DBS devices for Parkinson's for over 6 months.

I can safely get on and off a stationary bike with a backrest.

Exclusion Criteria

Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent

I have a condition that makes it hard for me to ride a bike.

I have a neurological condition, not Parkinson's, affecting my movement or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Session

Participants complete a single 150-minute session of both forced exercise (FE) and voluntary exercise (VE) in the OFF antiparkinsonian and Off-DBS state

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in cognitive and motor function through various tests

3 days

What Are the Treatments Tested in This Trial?

Interventions

• Forced and voluntary exercise

Trial Overview The study tests the effects of one session each of forced (FE) and voluntary exercise (VE) on cognitive function in PD patients without their usual medication or DBS stimulation. The exercises are done during a single 150-minute session.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

Two modes of high intensity exercise.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A new forced exercise intervention has shown promising results in improving motor function and central nervous system function in patients with Parkinson's disease, building on previous animal studies that indicated neuroprotective effects.

Traditional exercise methods have not provided significant overall improvements in function for Parkinson's patients, highlighting the potential of this novel approach to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Alberts, JL., Linder, SM., Penko, AL., et al.[2022]

Resistance Training (RT) is shown to significantly improve muscle strength in individuals with Parkinson's Disease, with a moderate effect size based on a meta-analysis of 15 randomized controlled trials.

All three exercise modalities—Resistance Training, Endurance Training, and Other Intensive Training Modalities—are safe and feasible, potentially benefiting balance, walking performance, and quality of life in Parkinson's Disease, with no reported deterioration in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy--a systematic review and meta-analysis of randomized controlled trials. Uhrbrand, A., Stenager, E., Pedersen, MS., et al.[2018]

Resistance training (RT) and endurance training (ET) are safe and feasible exercise modalities for people with Parkinson's disease, showing significant benefits in muscle strength, functional capacity, and quality of life based on a review of 33 new randomized controlled trials.

RT demonstrated a strong positive impact on muscle strength (SMD = 0.83) and functional capacity, while ET improved cardiorespiratory fitness (SMD = 0.27) and also showed potential benefits for functional outcomes, indicating that both types of exercise can be effective adjunct therapies for managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Gamborg, M., Hvid, LG., Dalgas, U., et al.[2022]

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]

Forced exercise may serve as a safe additional therapy for improving motor function in individuals with Parkinson's Disease, complementing existing medical treatments.

While exercise enhances the effectiveness of anti-parkinsonian medications, it does not reduce their side effects, highlighting the need for alternative approaches like forced exercise to support patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of forced exercise cycling in individuals with Parkinson's disease. Miner, DG., Aron, A., DiSalvo, E.[2021]

The SPARX Trial is a Phase II study involving 126 early-stage Parkinson's disease patients, designed to assess the feasibility and efficacy of high-intensity exercise as a treatment for PD symptoms, comparing it to moderate-intensity exercise and usual care.

The trial aims to determine if either exercise intensity can lead to meaningful clinical improvements in motor scores, while also ensuring participant safety and monitoring dropout rates, which will inform future large-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Moore, CG., Schenkman, M., Kohrt, WM., et al.[2021]

In a study involving 10 patients with mild to moderate Parkinson's disease, forced exercise (FE) led to a significant 35% improvement in motor function as measured by the Unified Parkinson's Disease Rating Scale, while voluntary exercise (VE) showed no improvement.

FE not only enhanced motor function but also improved bimanual dexterity and maintained these benefits for 4 weeks after the exercise program ended, suggesting that FE may positively alter central motor control processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Ridgel, AL., Vitek, JL., Alberts, JL.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3634143/

The Effect of Forced-Exercise Therapy for Parkinson's Disease ... Past work has demonstrated an abnormal motor connectivity in patients with PD compared to controls and subsequent normalization after treatment.

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

High-intensity Exercise May Reverse Neurodegeneration in ... High-intensity exercise induces brain-protective effects that have the potential to not just slow down, but possibly reverse, the neurodegeneration associated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3703838/

Parkinson's Disease and Forced Exercise: A Preliminary ... This study sought to ascertain any significant effect of forced exercise using a motorized stationary bicycle when compared to controls on Parkinson's disease ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2664948

Effect of High-Intensity Treadmill Exercise on Motor ... This phase 2 randomized clinical trial of 128 participants established that 80% to 85% and 60% to 65% exercise intensities are safe and feasible.

5. nature.com nature.com/articles/s41531-022-00418-4

A systematic review and meta-analysis on effects of ... Aerobic exercise had beneficial effects in improving balance, gait (velocity and stride/step length), and motor function in PD patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10621990/

Physical exercise and its effects on people with Parkinson's ... Findings of the systematic reviews suggest that all exercise categories can be prescribed to improve balance and mobility, while combined exercises, strength, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4574905/

Randomized Clinical Trial of 3 Types of Physical Exercise ... Outcomes of 67 Participants With Parkinson Disease Following Exercise ... Forced, not voluntary, exercise improves motor function in Parkinson's disease patients.