Actively Recruiting
Study in Parkinson Disease of Exercise
Led by Northwestern University · Updated on 2026-04-13
370
Participants Needed
25
Research Sites
361 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.
CONDITIONS
Official Title
Study in Parkinson Disease of Exercise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic Parkinson Disease based on modified UK PD brain bank criteria
- Hoehn and Yahr stage less than 3
- Disease duration less than 3 years since diagnosis
- Age between 40 and 80 years
- Positive DaTscan153 SPECT confirming Parkinson Disease
You will not qualify if you...
- Currently treated with PD medications such as levodopa, dopamine agonists, MAO-B inhibitors, amantadine, or anticholinergics
- Expected to require PD medication within first 6 months of study
- Use of any PD medication within 60 days before baseline visit or use for more than 60 days previously
- Use of neuroleptics or dopamine receptor blockers more than 30 days in the past year or within 30 days of baseline
- Known cardiovascular, metabolic, or renal disease without medical clearance
- Uncontrolled hypertension (resting BP >150/90 mmHg)
- Orthostatic hypotension with standing systolic BP below 100
- Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L)
- Abnormal liver or renal function beyond specified limits
- Abnormal complete blood count deemed clinically significant
- Recent use of unstable-dose psychotropic medications
- Serious illness requiring treatment or hospitalization within last 4 weeks
- Any other medical, psychiatric, or substance abuse condition interfering with participation
- Montreal Cognitive Assessment (MoCA) score below 24
- Beck Depression Inventory II (BDI) score above 28 or moderate depression with interference in participation
- Exercising at greater than moderate intensity (>60-65% HRmax) for 120 minutes or more per week in last 6 months
- Use of certain medications within 90 days prior to DaTscan153 SPECT
- Known allergy or hypersensitivity to iodinated products or DaTscan153 SPECT
- Women who are pregnant, breastfeeding, or planning pregnancy within 12 months
- Other conditions limiting ability to perform endurance exercise such as stroke, respiratory, brain injury, orthopedic, or neuromuscular disorders
AI-Screening
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Trial Site Locations
Total: 25 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Colorado, Denver
Aurora, Colorado, United States, 80204
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
5
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Active, Not Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Iowa State University
Ames, Iowa, United States, 50011
Actively Recruiting
10
Louisiana State University
Baton Rouge, Louisiana, United States, 70803
Actively Recruiting
11
Boston University (Charles River Campus)
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
14
Washington University St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
15
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
16
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
17
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
18
Ohio Health
Columbus, Ohio, United States, 43214
Actively Recruiting
19
Kent State University
Kent, Ohio, United States, 44240
Actively Recruiting
20
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
21
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
22
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
23
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
24
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
25
University of Alberta
Edmonton, Canada
Actively Recruiting
Research Team
E
Elizabeth Joslin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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