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Treadmill training may slow Parkinson's motor decline

NCT ID NCT04284436

Disease control Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether high-intensity treadmill exercise can slow the worsening of motor symptoms in people with early-stage Parkinson's disease. 370 participants who have not yet started Parkinson's medication will be assigned to either moderate or high-intensity treadmill sessions four times a week for 12 months. Researchers will measure changes in movement symptoms and brain dopamine activity to see if exercise helps control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

370 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • Boston University (Charles River Campus)

    Boston, Massachusetts, 02215, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Iowa State University

    Ames, Iowa, 50011, United States

  • Kent State University

    Kent, Ohio, 44240, United States

  • Louisiana State University

    Baton Rouge, Louisiana, 70803, United States

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio Health

    Columbus, Ohio, 43214, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Alberta

    Edmonton, Canada

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Colorado, Denver

    Aurora, Colorado, 80204, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Washington University St. Louis

    St Louis, Missouri, 63130, United States

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Other studies related to the condition(s) this trial covers.