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Endurance treadmill exercise for early stage Parkinson's disease

Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

Not applicable Interventional Northwestern University · NCT04284436

This study is testing if regular treadmill exercise can help people with early-stage Parkinson's disease slow down their symptoms before they start medication.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment370 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorNorthwestern University Academic / other
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT04284436 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of endurance treadmill exercise on the progression of Parkinson's disease in individuals who have not yet started medication. A total of 370 participants aged 40-80 with early-stage Parkinson's will be randomly assigned to two exercise intensity groups, performing treadmill workouts four times a week for 12 months. The primary outcome will be measured using the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score, while secondary outcomes will assess various aspects of mobility, cognition, and quality of life. The study will take place across approximately 29 sites in the USA and Canada, involving collaboration between movement disorders and exercise specialists.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-80 with early-stage idiopathic Parkinson's disease who have not initiated any dopaminergic therapy.

Not a fit: Patients currently on Parkinson's disease medications or expected to require treatment within the first 6 months of the study may not benefit.

Why it matters

Potential benefit: If successful, this approach could slow the progression of Parkinson's disease in patients who have not yet started medication.

How similar studies have performed: Other studies have shown promising results with exercise interventions in Parkinson's disease, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Parkinson Disease
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.