Clinical Trial Title
Study In Parkinson's Disease of ExerciseNational Clinical Trial Number:
NCT04284436Contact Information
Clinical Trial Protocol Description:
This study is a phase 3 multi-site, 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 (PD).
The primary objective is to test whether the progression of the signs of PD is attenuated at 12 months among persons who have not initiated medication for PD when they perform high-intensity endurance treadmill exercise.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a diagnosis of idiopathic Parkinson's disease with disease duration less than 3 years since diagnosis.
- Have Hoehn and Yahr stages less than 3.
- Are 40-80 years of age.
- Have a positive DaTscan™ SPECT by quantitative readout for idiopathic Parkinson disease.
You will be excluded from the study if any of the following criteria apply to you:
- Are currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics.
- Are 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).
- Have been exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.