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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02230267
Eligibility Criteria:
Inclusion Criteria:
* Neurologist-diagnosed idiopathic PD based on the UK PD brain bank criteria
* Aged 45-85
* Hoehn and Yahr stages 1-3 (mild to moderate PD)
* Participants do not anticipate a change in medication or surgical procedures in the next 8 months of the trial (2 months for the trial and 6 for the follow-up)
* Clearance from primary care physician to participate in the trial
* Must be stable on PD medication and DBS for 3 months prior to trial
Exclusion Criteria:
* Poorly controlled or unstable cardiovascular disease that precludes participation in exercise
* Moderate-to-severe dementia using the Montreal Cognitive Assessment (MoCA). We will exclude participants with a MoCA cut off score of \<26/30. This cut off value has excellent sensitivity (90%) and specificity (75%).
* Inability to stand or walk for more than 10 minutes
* Other significant disorders that would limit endurance exercise participation (i.e., osteoarthritis, stroke, respiratory problems, traumatic brain injury, neuromuscular disease, pain)
* Already participating in a regular, vigorous exercise program (3X/week or more of \>60% estimated maximum heart rate)
* Participants will be excluded from the trial if they are taking any medications that interfere with heart rate response to exercise
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT02230267
Study Brief:
Protocol Section:
NCT02230267