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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07443293
Eligibility Criteria:
Inclusion Criteria:
* Age 40-85 years
* A diagnosis of either PD, based on the Movement Disorder Society (MDS) criteria, OR, RBD, through a polysomnography
* Hoehn \& Yahr score of 1 to 2
* Able to fill out questionnaires
* Able to follow instructions and directions as required by the intervention.
* Have access to the necessary technologies (i.e., a working smartphone for Fitbit, a laptop or tablet for Zoom) as required by the intervention.
Exclusion Criteria:
* Any chronic medical condition which would affect ability to participate in exercise
* Any contraindication for exercise based on the Physical Activity Readiness for Everyone Questionnaire (PAR-Q+) and medical clearance form
* Significant cognitive impairment, depression, or eating disorder
* Score \<21/30 on the Montreal Cognitive Assessment (MoCA)
* Any contraindication to MRI scanning; such as implanted metal clips or wires (see list below)
* Participants who were told by a medical doctor that they need to be medically supervised for exercise
* Participants currently doing 180 minutes or more of moderate-vigorous intensity exercise per week AND either of the following:
Completion of a Mindfulness-Based Stress Reduction course OR; Score \>8/15 in the MIND Diet Questionnaire
* Significant or unstable cardiovascular or respiratory disease
* Severe/multiple head trauma(s)
* Subjects who are pregnant or breastfeeding
* Subjects with a history or major episodes of drug or alcohol abuse
* Chronic/acute bacterial/viral infection
* GI cancer
* Inflammatory bowel disease
Exclusion for MRI scanning:
* Individuals weighing \> 400 lbs (limit of MRI machine)
* Artificial heart valve
* Brain aneurysm clip
* Electrical stimulator for nerves or bones
* Ear or eye implant
* Implanted drug infusion pump
* Coil, catheter, or filter in any blood vessel
* Orthopedic hardware (artificial joint, plate, screws)
* Other metallic prostheses
* Shrapnel, bullets, or other metal fragments
* Surgery or tattoos (including tattooed eyeliner) in the last six weeks
* Brain surgery
* Have a cardiac pacemaker, wires or defibrillator
* Have had an injury where a piece of metal lodged in the eye or orbit
* Have a ferromagnetic aneurysm clip
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT07443293
Study Brief:
Protocol Section:
NCT07443293