Parkinson's DiseaseNCT07882446
Utilization of Aerobic Exercise to Maintain Neurologic Health
A study testing Aerobic Exercise in people with Parkinson's Disease, run by The Cleveland Clinic.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 15 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult identified as high-risk for developing PD within the next 24 months
- Age 55-65 years
- Demonstrate the ability to safely mount and dismount the Peloton stationary cycle
- In-home WiFi (Peloton system requires WiFi to transmit exercise data)
Who cannot join
- Diagnosis of neurocognitive impairment that compromises one's ability to provide informed consent.
- A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in aerobic exercise
- Neurological disease (i.e. multiple sclerosis, PD, stroke, etc.)
- Current cardiac arrhythmia
- Greater than 3 weeks of consecutive time away from home that would render the individual unable to complete the cycling protocol
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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).
- Conditions
- Parkinson's Disease
- Being tested
- Aerobic Exercise
- Keywords
- Exercise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Participants randomized into the aerobic exercise group will be asked to
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Fifty participants in the no exercise (control) group. No exercise intervention through the research |
| Exercise Group | Experimental | Fifty participants exercising remotely on a stationary cycle, targeting three times per week for 30-45 minutes per session. Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS III
Rater-observed PD global motor symptoms
Measured: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment
10 Meter Walk Test
Timed 10 meter walking task
Measured: Enrollment, 6month post-enrollment, 12 post-enrollment, 18 month post-enrollment, and 24 month-enrollment
University of Pennsylvania Smell Identification Test (UPSIT)
Olfaction function
Measured: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Dec 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Alberts, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882446
- Sponsor's protocol ID
- 26-1096
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Aerobic Exercise to Maintain Neurologic Health
- ClinicalTrials.gov ID
- NCT07882446
- Acronym / sponsor ID
- 26-1096
- Conditions
- Parkinson's Disease
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Groups
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Fifty participants in the no exercise (control) group. No exercise intervention through the research |
| Exercise Group | Experimental | Behavioral: Aerobic ExerciseFifty participants exercising remotely on a stationary cycle, targeting three times per week for 30-45 minutes per session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult identified as high-risk for developing PD within the next 24 months
- Age 55-65 years
- Demonstrate the ability to safely mount and dismount the Peloton stationary cycle
- In-home WiFi (Peloton system requires WiFi to transmit exercise data)
Key exclusion criteria (8 listed)
- Diagnosis of neurocognitive impairment that compromises one's ability to provide informed consent.
- A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in aerobic exercise
- Neurological disease (i.e. multiple sclerosis, PD, stroke, etc.)
- Current cardiac arrhythmia
- Greater than 3 weeks of consecutive time away from home that would render the individual unable to complete the cycling protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants randomized into the aerobic exercise group will be asked to | Behavioural | Exercise Group |
Primary outcome
MDS-UPDRS III
Time frame: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment
Rater-observed PD global motor symptoms
10 Meter Walk Test
Time frame: Enrollment, 6month post-enrollment, 12 post-enrollment, 18 month post-enrollment, and 24 month-enrollment
Timed 10 meter walking task
University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment
Olfaction function
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Alberts, PhD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Parkinson's Disease, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Jansen, MPH (216-780-9160, jansena@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS III (time frame: Enrollment, 12 months post-enrollment, and 24 Months post-enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.