Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS
Purpose
This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.
Conditions
- Parkinson's Disease
- Deep Brain Stimulation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinical diagnosis of Parkinson's disease - Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD - Clinically optimized DBS parameters for one month prior to enrollment - Ability to ambulate with or without an assistive device for 5 continuous minutes - Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments
Exclusion Criteria
- Neurocognitive impairment that compromises the ability to provide informed consent - Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) - Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen: 1. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation. 2. Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible. - A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise - Current cardiac arrhythmia
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Forced Exercise (FE) |
Participants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program using a stationary bike equipped with a motor that assists pedaling. The motor helps maintain a cadence higher than the participant's voluntary pace, typically around 80-90 revolutions per minute, while the participant continues to actively pedal. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored to ensure safety and maintain aerobic intensity. The goal is to provide consistent, high-rate cycling that participants likely could not achieve on their own. |
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|
Experimental Voluntary Exercise (VE) |
Participants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored for safety and consistency. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic
Detailed Description
This study is investigating how aerobic exercise, specifically forced exercise (FE) and voluntary exercise (VE), affects movement, thinking, and brain activity in people with advanced Parkinson's disease who have deep brain stimulation (DBS). Over eight weeks, 36 participants will complete either a forced cycling program (where a motor helps them pedal faster than they could on their own) or a voluntary cycling program at a self-driven pace. Participants will complete an 8-week delayed start period to serve as a comparison before starting an exercise program. The study will measure motor symptoms, cognitive performance, and brain activity from both the cortex (via EEG) and the subthalamic nucleus (via DBS device recordings) at several time points, including before treatment, after the 8-week exercise period, and again four weeks later. By analyzing how neural signals change at rest and during tasks, the study will evaluate the neural mechanisms that make exercise beneficial. This research could ultimately guide more effective, personalized exercise therapies to support people with advanced Parkinson's disease with DBS.