An interventional study of Aerobic Exercise in Parkinson's Disease, sponsored by The Cleveland Clinic. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention
A promising approach to combat the protein aggregation, oxidative stress, and neuroinflammation occurring with PD is consistent aerobic exercise. Dr. Alberts' recently completed Phase III Randomized Clinical Trial2,3 demonstrating that a specific aerobic exercise prescription was effective at slowing the progression of motor symptoms in mild to moderate Parkinson's disease patients. This project extends our positive findings by evaluating the effectiveness of this PD-specific exercise intervention in individuals identified as high-risk of converting to PD. The underlying hypothesis is that aerobic exercise can delay or prevent motor and cognitive decline associated with PD, as aerobic exercise is known to reduce oxidative stress and neuroinflammation and enhance mitochondria function.
Parkinson's disease is associated bradykinesia, resting tremor, rigidity and postural instability. Currently, there is no cure for PD. However, the field is transitioning from symptom management to "disease modification", developing treatments that slow or stop the underlying damage to neurons. It is theorized that disease modification approaches would be most effective very early in the disease, even before symptoms are visible, due to the potential for neuroplasticity at the stage of the disease when cell death is minimal. Identifying individuals at risk for developing a disease is challenging.
Our 2024 study, Explainable machine learning for predicting conversion to neurological disease: Results from 52,939 medical records,1 represents a major step forward in using routine healthcare data to identify risk of converting to neurodegenerative disease years before a formal clinical diagnosis. Briefly, by analyzing more than 52,000 electronic health records we developed a model to predict who is likely to convert to PD. The project is unique as it did not simply evaluate a "snapshot" of a patient's current health; it analyzed their longitudinal history to see how aspects of health changed over time. The models were effective at identifying risk even years before symptoms became obvious, suggesting that PD does not have a silent phase, rather changes are occurring that may be subtle and not observable through routine primary care visits. The model is currently active in EPIC in three Cleveland Clinic Primary Care locations.
One hundred individuals, otherwise healthy between 55-65 years of age, who are identified as at high risk for converting to PD based on our Explainable AI models will be recruited. Following a 30-day control period to establish baseline physical activity, individuals will be randomized to a UCC group (e.g., control group) or an AEX group. The control group will not engage in any formal intervention. Those randomized to AEX will complete aerobic exercise three times a week, 30+ minutes, for 24 months. The aerobic exercise intervention will be completed in the home of the individual using a commercially available Wi-Fi connected exercise cycle. All participants will complete Comprehensive Assessments (Baseline, 12, 24 months) and Interim assessments (6 and 18 months).
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Exclusion Criteria:
Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen4
Fifty participants in the no exercise (control) group. No exercise intervention through the research
Fifty participants exercising remotely on a stationary cycle, targeting three times per week for 30-45 minutes per session.
Behavioral: Aerobic Exercise
Participants randomized into the aerobic exercise group will be asked to
MDS-UPDRS III
Rater-observed PD global motor symptoms
Time frame: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment
10 Meter Walk Test
Timed 10 meter walking task
Time frame: Enrollment, 6month post-enrollment, 12 post-enrollment, 18 month post-enrollment, and 24 month-enrollment
University of Pennsylvania Smell Identification Test (UPSIT)
Olfaction function
Time frame: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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