Recruiting
Phase 2

Aerobic Exercise

Sponsor:

The Cleveland Clinic

Code:

NCT07442747

Conditions

Parkinson's Disease

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief summary:

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

Study ID

NCT07442747

Start date

Jul 8, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Exercise

Participants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.

Primary outcome measure

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) [ Time Frame: Baseline to EOT and Baseline to EOT+4 weeks ]
  • Relative Root Mean Square Error of a Grip Force Tracking Task [ Time Frame: Baseline to EOT and Baseline to EOT+4 weeks ]
  • Local Field Potential Subthalamic Nucleus Beta at Rest [ Time Frame: Baseline to EOT and Baseline to EOT+4 weeks ]

Central Contacts and Locations

Central contacts

MacKenzie Dunlap

216-219-3949dunlapm4@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

MacKenzie Dunlap

216-219-3949dunlapm4@ccf.org

Principal Investigator:

Jay L Alberts, PhD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Parkinson
  • Deep Brain Stimulation
  • Parkinson's disease
  • Deep Brain Stimulation Surgery
  • DBS
  • Exercise
  • exercise training
  • Parkinson disease
  • Parkinson's
  • Parkinson's Disease with Deep Brain Stimulation
  • Percept
  • Cycling
  • Aerobic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-07-28.