Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02676804
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT02676804
Study Brief:
Protocol Section:
NCT02676804