IMPACT 360: a 6-month exercise, mindfulness, and nutrition program for Parkinson's disease
IMPACT 360 Study for Parkinson's Disease
PHASE2 · University of British Columbia · NCT07443293
This study will test whether a combined 6-month program of exercise, mindfulness, and nutrition improves health measures in people aged 40–85 with Parkinson's disease or REM sleep behavior disorder.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University of British Columbia (other) |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07443293 on ClinicalTrials.gov |
What this trial studies
IMPACT 360 enrolls 60 participants aged 40–85 with early-stage Parkinson's disease (Hoehn & Yahr 1–2) or polysomnography-confirmed REM sleep behavior disorder and delivers a combined intervention of exercise, meditation, and dietary guidance. The design is a partial crossover: half begin the 6-month intervention after baseline while the other half complete 6 months of usual care then cross over to the intervention. Outcomes include eight key health indicators and mechanistic measures (including neuroimaging and microbiome measures) collected at baseline, after usual care, and after the intervention. Data collection combines remote monitoring (Fitbit, telehealth) with in-person visits and MRI when required.
Who should consider this trial
Good fit: Ideal candidates are people aged 40–85 with MDS-defined Parkinson's disease (Hoehn & Yahr 1–2) or polysomnography-confirmed RBD who can exercise, complete questionnaires, follow instructions, and use required technology.
Not a fit: Patients with advanced Parkinson's disease (Hoehn & Yahr >2), significant cognitive impairment (MoCA <21), major medical contraindications to exercise or MRI, or inability to use the required technology are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve motor and non-motor symptoms, overall well-being, and biological markers related to disease progression.
How similar studies have performed: Exercise, meditation, and dietary interventions individually have shown modest benefits in Parkinson's and neuroprotection research, but combined multimodal programs remain promising and not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver, British Columbia
- University of British Colombia — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Principal investigator: Silke Appel-Cresswell, MD, FRCPC — University of British Colombia
- Study coordinator: Jeffrey Kelly
- Email: jeff.kelly@ubc.ca
- Phone: 604-827-4230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease, REM Sleep Behavior Disorder, Exercise, Mindfulness, Nutrition, Microbiome, Well-Being