NCT04284436
Study in Parkinson Disease of Exercise
Active, Not Recruiting
NAAges 40–80InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~370 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Treadmill walking
At a glance
Recruiting sites
0 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in motor symptoms of Parkinson disease
Measured over 12 months
Conditions
NCT04284436
Where you'd take part
This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston University (Charles River Campus)
Boston, Massachusettsno site contact published
Cleveland Clinic
Cleveland, Ohiono site contact published
Columbia University Medical Center
New York, New Yorkno site contact published
Emory University
Atlanta, Georgiano site contact published
Iowa State University
Ames, Iowano site contact published
Kent State University
Kent, Ohiono site contact published
Louisiana State University
Baton Rouge, Louisianano site contact published
Morehouse School of Medicine
Atlanta, Georgiano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Daniel M Corcos, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
A diagnosis of idiopathic Parkinson Disease based on the modified \* United Kingdom (UK) PD brain bank criteria and which are consistent with recent criteria proposed for clinically established early established Parkinson's disease that no longer exclude individuals with a family history of Parkinson's disease.
Hoehn and Yahr stages less than 3
Disease duration: less than 3 years since disease diagnosis
Age 40-80 years
Positive DaTscan™ SPECT by quantitative readout for idiopathic Parkinson disease.
Exclusion
Currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics.
Expected to require treatment with medication for PD in the first 6 months of the study.
Use of any PD medication 60 days prior to the baseline visit including but not limited to levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
Duration of previous use of medications for PD exceeds 60 days.
Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior to baseline visit, or any use within 30 days of baseline visit
Presence of known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program.
Uncontrolled hypertension (resting blood pressure \>150/90 mmHg)
Individuals with orthostatic hypotension and standing systolic BP below 100 will be excluded. Orthostatic hypotension (OH) is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing.
Hypo- or hyperthyroidism (TSH \<0.5 or \>5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal), abnormal renal function (estimated glomerular filtration rate (eGFR) using the MDRD4 equation or the CKD-EPI equation \<45mL/min/1.73m2 ).
Complete Blood Count (CBC) out of range and physician's judgment that abnormal value is clinically significant.
Recent use of psychotropic medications (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for 28 days prior to screening.
Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks.
Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, assessment or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject's ability to participate in the study.
Montreal Cognitive Assessment (MoCA) score of \<24.
Beck Depression Inventory II (BDI) score \> 28, indicating severe depression that precludes ability to exercise. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression. Individuals with a BDI-II score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.
Individuals who have been exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months will be excluded. Greater than moderate intensity is defined as a range greater than 60-65% HRmax. These individuals are excluded since their exercise activities are greater than the activities they would experience if they were assigned to the 60-65% treatment group. As such, they would be expected to lose fitness.
Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine derivative, or use of buproprion within 8 days prior to the DAT neuroimaging screening evaluation. These can compromise DaTscan™ SPECT.
Known allergy to iodinated products.
Known hypersensitivity to DaTscan™ SPECT (either to the active substance of 123I-ioflupane or any of the excipients.
(For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months.
Other disorders, injuries, diseases, or conditions that might interfere with ability to perform endurance exercises (e.g. history of stroke, respiratory problems, traumatic brain injury, orthopedic injury, or neuromuscular disease).
What this trial measures
- Change in motor symptoms of Parkinson disease12 months
Change from baseline in the Movement Disorders Society-Unified Parkinson Disease Rating Scale motor score (Part III). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms.