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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT07221994
Eligibility Criteria:
Inclusion Criteria:
1. Age 18+
2. People with advanced Parkinson's disease. "Advanced PD" will include signs of progressed disease including orthostatic hypotension and/or motor issues reflective of postural instability and/or mild-moderate bilateral symptoms (confirmed visually in clinic or home by a medical provider such as an MD/PT and/or documented in the medical record.
3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. Diagnosis of idiopathic Parkinson's disease (self-reported okay, documented preferred)
5. Independent ambulation (≥10m with or without an assistive device)
6. Commitment to participate in the exercise intervention as outlined
7. Score of ≥21 on the Montreal Cognitive Assessment (MoCA)
Exclusion Criteria:
1. History of cardiovascular disease, uncontrolled hypertension (blood pressure
≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis which a patient's primary physician determines would preclude them from safe study participation.
2. Ankle branchial index ≤ 0.9 or \> 1.3
3. History of or comorbid conditions spanning cardiovascular, neurological, or orthopedic injuries which may prevent for the safe administration of the intervention (a healthcare provider's clearance or guidance will be obtained in these situations to ensure appropriateness), including current medications.
4. History of uncontrolled diabetes, BMI \> 40, or severe cognitive impairment (as measured by MoCA \<21)
5. Atypical PD diagnoses or ON PD-medication worsening of motor symptoms
6. Absolute contraindications to exercise as per the American College of Sports Medicine (uncontrolled arrhythmias, third-degree heart block, recent electrocardiogram (EKG) changes, unstable angina, acute myocardial infarction, or acute congestive heart failure)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07221994
Study Brief:
Protocol Section:
NCT07221994