36 Participants NeededMy employer runs this trial

Exercise for Parkinson's Disease

MD
Overseen ByMacKenzie Dunlap
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different types of cycling exercise affect people with Parkinson's disease who have deep brain stimulation devices. Researchers aim to determine if forced cycling (with a motor assisting to maintain a fast pace) differs from self-paced cycling. They seek to understand how these exercises impact movement, thinking, and brain activity. Individuals with Parkinson's disease who use a deep brain stimulation device and can walk for five minutes might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both guided and self-paced aerobic exercise can be safely managed for people with Parkinson's disease, including those with deep brain stimulation devices.

For guided exercise, studies have found significant improvements in Parkinson's symptoms. Research suggests that guided exercise safely complements regular medical care. Specifically, participants in a cycling program experienced a 30% improvement in symptoms and a slower progression of movement issues over a year.

For self-paced exercise, similar benefits have been observed. Patients reported symptom improvements after just a few days of cycling independently. Research also indicates enhanced thinking and decision-making skills following regular cycling exercises.

Overall, both exercise methods have been well-tolerated by participants, with safety measures like heart rate checks ensuring safe exercise levels.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these exercise treatments for Parkinson's Disease because they offer unique approaches to managing symptoms beyond traditional medications like levodopa and dopamine agonists. The Forced Exercise (FE) treatment uses a motor-assisted stationary bike to help participants maintain a high pedaling cadence, potentially improving motor function more effectively than self-paced activity. Meanwhile, the Voluntary Exercise (VE) treatment encourages participants to find their optimal cycling pace while still targeting aerobic intensity, making it more adaptable to individual fitness levels. Both approaches focus on enhancing physical activity, which could complement existing therapies and improve quality of life for individuals with Parkinson's.

What evidence suggests that this trial's exercise treatments could be effective for Parkinson's disease?

Research has shown that aerobic exercise can benefit people with Parkinson's disease (PD). In this trial, participants will join one of two exercise groups. The "Forced Exercise" group will cycle with assistance to maintain a high speed, which studies have found can improve movement and slow symptom progression. Specifically, one study reported better movement and hand coordination with faster cycling. Meanwhile, the "Voluntary Exercise" group will cycle at their own pace while maintaining an elevated heart rate, which also appears to aid movement and mobility. Both types of cycling—whether assisted or self-paced—have demonstrated improvements in balance and walking. Overall, aerobic exercise, whether intense or at one's own speed, seems to positively affect Parkinson's symptoms.678910

Who Is on the Research Team?

JL

Jay L Alberts, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Parkinson's disease who already have a Medtronic Percept deep brain stimulation (DBS) device. Participants must be able to walk for at least 5 minutes, have stable DBS settings, and be willing to pause their medication and DBS during assessments.

Inclusion Criteria

Clinically optimized DBS parameters for one month prior to enrollment
I have been diagnosed with Parkinson's disease.
I can walk for 5 minutes, with or without help.
See 2 more

Exclusion Criteria

I do not have memory or thinking problems that affect my ability to consent.
Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen requiring medical clearance prior to participation
I currently have an irregular heartbeat.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants maintain usual activities and wear an activity monitoring device

8 weeks
Weekly check-ins (virtual)

Treatment

Participants engage in an 8-week cycling program, either forced or voluntary, with sessions three times per week

8 weeks
24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Aerobic Exercise

Trial Overview

The study compares the effects of two types of aerobic cycling—forced and voluntary—on movement, thinking skills, and brain activity in people with Parkinson's disease who use DBS devices.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Voluntary Exercise (VE)Experimental Treatment1 Intervention
Group II: Forced Exercise (FE)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

The cyclical lower extremity exercise for Parkinson's trial ...

CYCLE trial will play a critical role in determining the effectiveness of two different types of aerobic exercise, forced and voluntary, on motor and non-motor ...

Therapeutic effects of forced exercise cycling in individuals ...

Early studies have shown forced exercise produces promising results with regard to improvement in motor function including some of the cardinal features of PD ...

A systematic review and meta-analysis on effects of aerobic ...

Aerobic exercise had beneficial effects in improving balance, gait (velocity and stride/step length), and motor function in PD patients. However, aerobic ...

Is Forced High Cadence Cycling A More Effective Method than ...

Results: The forced exercise group demonstrated greater improvements on the Unified Parkinson Disease Rating Scale motor scores and Timed Up and Go. Page 2 ...

The cyclical lower extremity exercise for Parkinson's trial ...

forced exercise cycling, results in global improvements in the cardinal symptoms of Parkinson's disease.

Cycling fast to slow Parkinson's: High-rate exercise ...

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

Therapeutic effects of forced exercise cycling in individuals ...

Collectively, the evidence provided in this review suggests that forced exercise may be safely added as an ancillary therapy to the medical management of PD.

NCT02175082 | Cycling in Parkinson's Disease

Outcomes: Gait parameters of step length, width, and variability as measured by the GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise ...

Therapeutic effects of forced exercise cycling in individuals ...

Collectively, the evidence provided in this review suggests that forced exercise may be safely added as an ancillary therapy to the medical ...