Exercise Dosing Trial for Individuals With Parkinson's Disease (PDEX)

This is an interventional supportive care trial for Parkinsons Disease focused on measuring Exercise Read More

Inclusion Criteria:

• Subjects with idiopathic Parkinson Disease as determined by United Kingdom Brain Bank Criteria. This includes the presence of bradykinesia with one or both of the following: rest tremor and/or rigidity
• Asymmetric onset of PD and progressive motor symptoms.
• Hoehn and Yahr stage 2 or 3.
• Stable dopaminergic medication regimen for 4 weeks prior to baseline visit with no anticipated changes for the duration of the study.
• Stable doses of medications known to affect sleep and medications for Parkinson's Disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
• Ability to complete exercise intervention and assessment visits during at least 16 weeks of intervention (3x/week for 16 weeks).
• Must pass a physical examination to assess exercise readiness.
• Women of childbearing potential may enroll but must use a reliable measure of contraception and have a negative serum pregnancy test at the screening visit.
• Montreal Cognitive Assessment score ≥ 18 and ≤30.
• Ability to pass a Physical Activity Readiness Questionnaire to assess exercise readiness.

Exclusion Criteria:

• Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
• Neuroleptic treatment at time of onset of Parkinsonism
• Active treatment with a neuroleptic at time of study entry. Exceptions to this are quetiapine and clozapine.
• History of multiple strokes with stepwise progression of Parkinsonism
• History of multiple head injuries
• Inability to walk without assistance, including a cane, wheelchair, or walker
• Regular participation in an exercise program within the past 6 months.
• Deep Brain Stimulation or other neurosurgical procedure for PD.
• Untreated sleep apnea
• Known narcolepsy
• Participation in drug studies or the use of investigational drugs within 30 days prior to screening
• Acute illness or active, confounding medical, neurological, or musculoskeletal conditions that, at the discretion of the PI, would prevent the subject's ability to participate in the study
• Known contraindication to testing
• Active alcoholism or other drug addiction
• Pregnancy
• Moderate to severe dementia