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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT04796506
Eligibility Criteria:
Inclusion:
* clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as at least one of the following: rest tremor, rigidity, and/or postural instability (per United Kingdom PD Brain Bank Criteria)
* Hoehn and Yahr stage 2-3 (performed at screening visit)
* age ≥ 45 and
* on stable medications for at least 4 weeks prior to study entry without expecting to change medications for the duration of the study.
* Montreal Cognitive Assessment (MoCA) score ≥ 18 and \<26 (performed at screening visit)
* No contraindications to an exercise program.
Exclusion:
* fails exercise readiness evaluation at screening visit
* regular participation in an exercise program
* cardiovascular or pulmonary disease, including uncontrolled hypertension, congestive heart failure, unstable coronary artery disease, serious arrhythmia, stroke within the past year, or chronic obstructive pulmonary disease (COPD)
* shift workers
* signs indicative of atypical Parkinsonism (cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs)
* secondary Parkinsonism (neuroleptic treatment at time of onset of Parkinsonism or at time of study entry, history of multiple strokes with stepwise progression of Parkinsonism, or history of multiple head injuries)
* inability to walk without assistance
* deep brain stimulation (DBS)
* known narcolepsy
* untreated sleep apnea
* any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
100 Years
Study:
NCT04796506
Study Brief:
Protocol Section:
NCT04796506