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

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Fifteen PwPD who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre-, during FE or VE and post-exercise). The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III Motor Exam and upper extremity force-tracking task will be used to determine motor response to exercise.

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.

Is exercise safe for people with Parkinson's Disease?

Research shows that different types of exercise, including resistance training, endurance training, and forced exercise, are safe for people with Parkinson's Disease and do not worsen symptoms. ^{1 2 3 4 5}

How does the treatment 'Exercise for Parkinson's Disease' differ from other treatments for this condition?

This treatment is unique because it involves both forced and voluntary aerobic exercise, which can improve motor symptoms and potentially slow disease progression in Parkinson's patients. Unlike traditional drug treatments, this approach focuses on enhancing physical fitness and movement initiation through high-intensity exercise, offering benefits like improved gait and reduced tremors. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Forced and Voluntary Exercise for Parkinson's Disease?

Research shows that aerobic exercise, including forced and voluntary exercise, can improve motor symptoms and movement initiation in Parkinson's Disease patients. Forced exercise, in particular, has been highlighted as potentially more effective in improving motor function. ^{2 3 5 6 7}

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

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic effects of forced exercise cycling in individuals with Parkinson's disease. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mobility improves after high intensity aerobic exercise in individuals with Parkinson's disease. [2020]

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

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. [2021]

7. Denmark pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. [2022]

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

Current Perspectives on Aerobic Exercise in People with Parkinson's Disease. [2022]

9. England 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. [2022]