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Behavioural Intervention
Aerobic Exercise for Parkinson's Disease (GEARS Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Jay Alberts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hoehn and Yahr stage I-III
Adult with a diagnosis of PD by a physician or physician extender
Must not have
Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
Current cardiac arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment on and off medications, 6 months post-enrollment, and 12 months post-enrollment
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how genetics and exercise can impact the progression of Parkinson's Disease (PD). They will recruit 200 PD patients from Cleveland and Salt Lake City to participate in a community-based exercise
Who is the study for?
Adults with Parkinson's Disease (PD) stages I-III who can safely use a stationary bike, have reliable transport to the exercise facility, and own a smartphone for monitoring activity. They must be on stable PD medication.
What is being tested?
The trial is testing if high-intensity cycling 3 times a week at community sites can slow down PD progression. It also examines how genetics might influence this effect. Participants will cycle for one year and undergo genetic testing.
What are the potential side effects?
While specific side effects are not listed, high-intensity exercise may cause fatigue, muscle soreness or strain, increased heart rate during activity, and potential falls or injuries related to using the stationary bike.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's disease is in the early to mid-stage.
Select...
I have been diagnosed with Parkinson's disease by a healthcare professional.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological condition that is not Parkinson's disease.
Select...
I have a heart rhythm problem.
Select...
I have deep brain stimulation or focused ultrasound for Parkinson's.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment on and off medications, 6 months post-enrollment, and 12 months post-enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment on and off medications, 6 months post-enrollment, and 12 months post-enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MDS-UPDRS III
Secondary study objectives
Nine Hole Peg Test
Processing Speed
Six Minute Walk Test
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Interventional ArmExperimental Treatment1 Intervention
All participants will exercise in a community setting 3x/week for 12 months
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,058 Total Patients Enrolled
Jay AlbertsLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
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