RECRUITINGPhase 2INTERVENTIONAL

IMPACT 360 for Parkinson's Disease

IMPACT 360 Study for Parkinson's Disease

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

Exercise

The intervention will involve online (via University of British Colombia (UBC) Zoom videoconferencing) 1-hour moderate to high intensity exercise classes 3 times a week for 6 months.

BEHAVIORAL

Meditation

The intervention will involve 15 minute guided mediation following exercise classes as well as mindfulness classes. Mindfulness classes will consist of 1.5 hour Mindfulness Based Stress Reduction (MBSR) classes for the first 2 months, followed by 1 month of 1 hour bi-weekly discussions and practice, then MBSR 2.0 for months 4 and 5, and 1 hour bi-weekly discussions and practice for the remaining month of the intervention.

BEHAVIORAL

Diet

The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.

Locations (1)

University of British Colombia

Vancouver, British Columbia, Canada