Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
370 participants
INTERVENTIONAL
2021-08-30
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High Intensity Exercise
Treadmill exercise 4x per week at 80-85% HRmax.
Treadmill walking
Treadmill walking 4 days per week for 30 minutes in the target heart rate
Moderate Intensity Exercise
Treadmill exercise 4x per week at 60-65% HRmax.
Treadmill walking
Treadmill walking 4 days per week for 30 minutes in the target heart rate
Interventions
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Treadmill walking
Treadmill walking 4 days per week for 30 minutes in the target heart rate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
40 Years
80 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
The Parkinson Study Group
NETWORK
Northwestern University
OTHER
Responsible Party
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Daniel Corcos
Professor of Physical Therapy and Human Movement Sciences
Principal Investigators
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Daniel M Corcos, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Iowa State University
Ames, Iowa, United States
Louisiana State University
Baton Rouge, Louisiana, United States
Boston University (Charles River Campus)
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio Health
Columbus, Ohio, United States
Kent State University
Kent, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
UT Health San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Alberta
Edmonton, , Canada
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Krista Nelles
Role: primary
References
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Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14.
Patterson CG, Joslin E, Gil AB, Spigle W, Nemet T, Chahine L, Christiansen CL, Melanson E, Kohrt WM, Mancini M, Josbeno D, Balfany K, Griffith G, Dunlap MK, Lamotte G, Suttman E, Larson D, Branson C, McKee KE, Goelz L, Poon C, Tilley B, Kang UJ, Tansey MG, Luthra N, Tanner CM, Haus JM, Fantuzzi G, McFarland NR, Gonzalez-Latapi P, Foroud T, Motl R, Schwarzschild MA, Simuni T, Marek K, Naito A, Lungu C, Corcos DM; SPARX3-PSG Investigators. Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial. Trials. 2022 Oct 6;23(1):855. doi: 10.1186/s13063-022-06703-0.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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