Active — Not RecruitingPhase 2

IMPACT 360 for Parkinson's Disease

Canada60 participantsStarted 2024-10-28

Plain-language 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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/vira…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognition - NIH Toolbox Cognitive Battery

Timeframe: 6 Months

Cognition- Montreal Cognitive Assessment

Timeframe: 6 Months

Cognition- Parkinson's Disease Cognitive Rating Scale [Time Frame: 6 Months]

Timeframe: 6 Months

Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein

Timeframe: 6 Months

Inflammation and Biomarkers in Serum - Interleukin-1β

Timeframe: 6 Months

Inflammation and Biomarkers in Serum - Interleukin-6

Timeframe: 6 Months

Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha

Timeframe: 6 Months

Trial details

NCT IDNCT07443293

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Parkinson's Disease (PD) trials

Plain-language summary

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cognition - NIH Toolbox Cognitive Battery

Timeframe: 6 Months

Cognition- Montreal Cognitive Assessment

Timeframe: 6 Months

Cognition- Parkinson's Disease Cognitive Rating Scale [Time Frame: 6 Months]

Timeframe: 6 Months

Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein

Timeframe: 6 Months

Inflammation and Biomarkers in Serum - Interleukin-1β

Timeframe: 6 Months

Inflammation and Biomarkers in Serum - Interleukin-6

Timeframe: 6 Months

Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha

Timeframe: 6 Months