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IMPACT 360 for Parkinson's Disease

RECRUITINGPhase 2Sponsored by University of British Columbia
Actively Recruiting
PhasePhase 2
SponsorUniversity of British Columbia
Started2024-10-28
Est. completion2027-05-31
Eligibility
Age40 Years – 85 Years
Healthy vol.Accepted

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

Age: 40 Years – 85 YearsHealthy volunteers accepted
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

Parkinson's DiseaseParkinson's Disease (PD)REM Sleep Behavior Disorder

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