IMPACT 360 for Parkinson's Disease

IMPACT 360 Study for Parkinson's Disease

IMPACT 360 for Parkinson's Disease (NCT07443293) is a Phase 2 interventional studying Parkinson's Disease (PD) and REM Sleep Behavior Disorder, sponsored by University of British Columbia. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Parkinson's Disease (PD) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Parkinson's Disease (PD) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of British Colombia

Vancouver, British Columbia, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07443293), the sponsor (University of British Columbia), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07443293 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07443293?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07443293?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07443293. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07443293. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.