IMPACT 360 for Parkinson's Disease
NCT07443293
Summary
The IMPACT 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 40 to 85 with a current diagnosis Parkinson's disease will be recruited. This study will follow a partial crossover design. All participants will receive the intervention. Participants randomized into the intervention group after their baseline screening will receive the 6-month intervention. Those randomized into the waitlist group will complete another assessment at the end of the 6-month care as usual phase before receiving the intervention.
Eligibility
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
Conditions3
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NCT07443293