| Registry | NCT07882446 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 100 (Estimated) |
| Sponsor | The Cleveland Clinic (Other) |
| Conditions | Parkinson's Disease |
| Interventions | Aerobic Exercise (Behavioral) |
| Dates | start 2026-12-15 (estimated), primary completion 2030-12-15 (estimated), completion 2030-12-15 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson's Disease All trials of Aerobic Exercise
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group | No intervention | Fifty participants in the no exercise (control) group. No exercise intervention through the research | |
| Exercise Group | Experimental | Behavioral: Aerobic Exercise | Fifty participants exercising remotely on a stationary cycle, targeting three times per week for 30-45 minutes per session. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Adult identified as high-risk for developing PD within the next 24 months 2. Age 55-65 years 3. Demonstrate the ability to safely mount and dismount the Peloton stationary cycle 4. In-home WiFi (Peloton system requires WiFi to transmit exercise data) Exclusion Criteria: 1. Diagnosis of neurocognitive impairment that compromises one's ability to provide informed consent. 2. A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in aerobic exercise 3. Neurological disease (i.e. multiple sclerosis, PD, stroke, etc.) 4. Current cardiac arrhythmia 5. Greater than 3 weeks of consecutive time away from home that would render the individual unable to complete the cycling protocol 6. Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen4 * If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation. * 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.