NCT07443293Active, not recruitingPhase 2
IMPACT 360 for Parkinson's Disease
IMPACT 360 Study for Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- 28 Oct 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of British Columbia
- Diseases
- Parkinson disease
- NCT number
- NCT07443293
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 28 Oct 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with a history or major episodes of drug or alcohol abuse
- Ear or eye implant
- Implanted drug infusion pump
- Surgery or tattoos (including tattooed eyeliner) in the last six weeks
- Brain surgery
Other illness
- Any chronic medical condition which would affect ability to participate in exercise
- Significant cognitive impairment, depression, or eating disorder
- Significant or unstable cardiovascular or respiratory disease
- Chronic/acute bacterial/viral infection
- GI cancer
- Inflammatory bowel disease
- Exclusion for MRI scanning:
- Artificial heart valve
- Have a cardiac pacemaker, wires or defibrillator
Lab values
- Any contraindication for exercise based on the Physical Activity Readiness for Everyone Questionnaire (PAR-Q+) and medical clearance form
Other
- 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
- Severe/multiple head trauma(s)
- Subjects who are pregnant or breastfeeding
- Individuals weighing \> 400 lbs (limit of MRI machine)
- Brain aneurysm clip
- Electrical stimulator for nerves or bones
- Coil, catheter, or filter in any blood vessel
- Orthopedic hardware (artificial joint, plate, screws)
- Other metallic prostheses
- Shrapnel, bullets, or other metal fragments
- Have had an injury where a piece of metal lodged in the eye or orbit
- Have a ferromagnetic aneurysm clip
Who the study is looking for
- 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.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of British Colombia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.