Exercise for Parkinson's Disease

Overseen By Jay L Alberts, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jay Alberts

Disqualifiers: Dementia, Neurocognitive impairment, Musculoskeletal issues, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise affect people with Parkinson's disease who have undergone deep brain stimulation (DBS) surgery. It will track brain activity during high-intensity cycling exercises, both when participants push themselves (Forced Exercise) and when they choose their pace (Voluntary Exercise). Researchers aim to determine how these exercise sessions impact movement and motor skills. Suitable candidates have Parkinson's, underwent DBS surgery at least six months ago, and can safely use a stationary bike. Participants should be willing to temporarily stop their Parkinson's medication and DBS during the trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can improve life after DBS surgery.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your antiparkinsonian medication and DBS stimulation for this trial.

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

Research shows that aerobic exercise is generally safe for people with Parkinson's Disease (PD). One study found that aerobic exercise improved balance, movement, and disease severity in 14 patients with mild to moderate PD. Another study suggested that high-intensity exercise might protect brain cells that produce dopamine, a chemical that helps control movement.

However, caution is important. People with PD may have a higher risk of falling, so safety measures should be in place during exercise. Overall, exercise, whether done independently or with assistance, appears well-tolerated and may offer additional benefits for those with PD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of forced and voluntary exercise for Parkinson's Disease because these approaches explore how physical activity could directly influence disease symptoms. Unlike standard treatments that primarily involve medications like Levodopa to manage symptoms, exercise offers a non-pharmacological option that might improve motor function and overall quality of life. Forced exercise, in particular, involves assisted movements that might provide benefits even for those with advanced symptoms, potentially acting on brain pathways differently than voluntary movements. This trial could uncover how varying intensities and types of exercise specifically benefit Parkinson's patients, offering new avenues for symptom management beyond traditional drug therapies.

What evidence suggests that exercise is effective for Parkinson's Disease?

This trial will explore the effects of two modes of high-intensity exercise for people with Parkinson's disease. Research has shown that exercise, whether voluntary or assisted, can benefit individuals with Parkinson's. One study found that both exercise types improved heart and lung fitness, but only the assisted exercise group showed better scores on a movement abilities test. Another review found that aerobic exercise can enhance balance, walking speed, and motor skills in people with Parkinson's. High-intensity exercise might also help protect the brain cells that produce dopamine, crucial for movement. Overall, regular physical exercise plays an important role in managing symptoms and maintaining physical health in Parkinson's disease. ^{3 6 7 8 9}

Who Is on the Research Team?

Jay Alberts, PhD

Principal Investigator

Staff

Are You a Good Fit for This Trial?

This trial is for adults with Parkinson's Disease (PD) who have had Deep Brain Stimulation (DBS) surgery using the Medtronic Percept system at least six months ago. Participants must be able to use a stationary cycle and agree to stop PD medications and DBS stimulation during the study. They need exercise clearance, but can't join if they have dementia, other neurological diseases, musculoskeletal issues affecting cycling ability, or uncontrolled cardiovascular conditions.

Inclusion Criteria

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

I am willing to stop my Parkinson's medication and deep brain stimulation.

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

Exclusion Criteria

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

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

I do not have uncontrolled heart issues or untreated blood clots.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Session

Participants complete a forced exercise (FE) and voluntary exercise (VE) session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN is continuously recorded for 130 minutes.

1 week

2 visits (in-person)

Data Collection

Data collection for primary outcome measures including Finger Tapping, Force Tracking, and Local Field Potential on days two and three.

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exercise sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Forced and Voluntary Exercise

Trial Overview The study examines how forced and voluntary exercise on a stationary bike affects neural activity in the Subthalamic Nucleus of people with PD who've undergone DBS surgery. It measures brain activity before, during, and after exercise sessions while participants are off their PD medication.

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?

Jay Alberts

Lead Sponsor

Trials

3

Recruited

220+

Published Research Related to This Trial

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]

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]

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 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]

An 8-week high-intensity aerobic exercise program significantly improved functional locomotor performance in 59 participants with Parkinson's disease, as measured by the Timed Up and Go (TUG) test.

Both forced and voluntary exercise modes led to faster TUG times and improvements in specific mobility tasks, such as turning velocity and gait speed, highlighting the potential of aerobic exercise to enhance mobility and reduce fall risk in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobility improves after high intensity aerobic exercise in individuals with Parkinson's disease. Miller Koop, M., Rosenfeldt, AB., Alberts, JL.[2020]

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]

A 12-week study involving 24 patients with Parkinson's disease showed that both active and passive assistive forced exercise improved gait and reduced symptoms, but active exercise had additional long-term benefits.

Active assistive forced exercise not only improved gait velocity and stride length but also significantly reduced tremors, suggesting it may be a more effective treatment option for managing Parkinson's disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active assistive forced exercise provides long-term improvement to gait velocity and stride length in patients bilaterally affected by Parkinson's disease. Stuckenschneider, T., Helmich, I., Raabe-Oetker, A., et al.[2022]

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]

Aerobic exercise is a safe and effective complementary treatment for people with Parkinson's disease, showing significant improvements in physical fitness (VO2max) and motor symptoms, particularly when performed at higher intensities.

While aerobic exercise offers general health benefits and may reduce cardiovascular risks, there is currently insufficient evidence regarding its impact on health-related quality of life and non-motor symptoms in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Perspectives on Aerobic Exercise in People with Parkinson's Disease. Schootemeijer, S., van der Kolk, NM., Bloem, BR., et al.[2022]

Citations

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

Parkinson's Disease and Forced Exercise: A Preliminary ... They found that both the voluntary exercise and forced exercise groups improved aerobically but only the FE group experienced an improved UPDRS score and better ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5897963/

Physical Exercise For Parkinson's Disease: Clinical And ... CONCLUSION. Physical exercise contributes to the treatment of Parkinson's disease, and can play a preventive role and maintain physical fitness and health.

3. 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.

4. medicine.yale.edu 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.

5. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.935176/full

Effectiveness of aerobic and resistance training on the ... Our results show that different aerobic and resistance training showed effects in PD patients, reflecting the complementary efficacy of aerobic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9622812/

A systematic review and meta-analysis on effects of aerobic ... Mehmet et al. reported that 14 patients with mild to moderate PD showed improvement in disease severity, balance, functional mobility, and upper ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923012503

Current Perspectives on Aerobic Exercise in People with ... Aerobic exercise seems a safe intervention for people with PD, although care must be taken to avoid falls in at-risk individuals. Further studies are needed to ...

8. nature.com nature.com/articles/s41531-025-01113-w

New perspectives on molecular mechanisms underlying ... Epidemiological findings suggest that physical activity may lower PD risk by protecting dopaminergic neurons, repairing motor control circuits, ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01636297

The Cyclical Lower-extremity Exercise for Parkinson's Trial ... Similar to our initial study, PD patients completing an 8-week forced-exercise intervention exhibited nearly a 25% percent improvement in clinical motor ratings ...