Exercise for Parkinson's (NCT07443293)
Slow Parkinson progression through lifestyle
- Trial ID
- NCT07443293
- Official Title
- IMPACT 360 Study for Parkinson's Disease
- Goal
- Slow Parkinson progression through lifestyle
- Phase
- PHASE2
- Status
- ACTIVE_NOT_RECRUITING
- Sponsor
- University of British Columbia
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease (PD), REM Sleep Behavior Disorder
- Interventions
- Exercise, Meditation, Diet
Summary For Families
IMPACT 360 is testing whether a coordinated program of exercise, meditation, and a brain-healthy diet can improve motor symptoms, reduce REM sleep behavior disorder events, and support thinking and overall quality of life in people with early Parkinson's or isolated RBD. The program pairs guided physical training to build strength, balance, and endurance, mindfulness meditation to lower stress and improve sleep and attention, and a MIND-style diet to reduce inflammation and support brain cells; these lifestyle changes are meant to complement, not replace, medications like levodopa. The study is enrolling adults 40 to 85 with early-stage Parkinson's (Hoehn and Yahr 1-2) or polysomnography-confirmed RBD who can follow instructions and use a smartphone and a computer for remote sessions. People with significant cognitive impairment (MoCA <21), medical or cardiac contraindications to exercise, current heavy exercisers or those who already completed an MBSR course or score high on the MIND diet, or anyone with MRI contraindications are excluded.
Locations
- University of British Colombia, Vancouver, British Columbia, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exercise. IMPACT 360 is testing whether a coordinated program of exercise, meditation, and a brain-healthy diet can improve motor symptoms, reduce REM sleep behavior disorder events, and support thinking and overall quality of life in people with early Parkinson's or isolated RBD. The program pairs guided physical training to build strength, balance, and endurance, mindfulness meditation to lower stress and improve sleep and attention, and a MIND-style diet to reduce inflammation and support brain cells; these lifestyle changes are meant to complement, not replace, medications like levodopa. The study is enrolling adults 40 to 85 with early-stage Parkinson's (Hoehn and Yahr 1-2) or polysomnography-confirmed RBD who can follow instructions and use a smartphone and a computer for remote sessions. People with significant cognitive impairment (MoCA <21), medical or cardiac contraindications to exercise, current heavy exercisers or those who already completed an MBSR course or score high on the MIND diet, or anyone with MRI contraindications are excluded.
- Who can participate?
- Participants must be between 40 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 2 years and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- How many visits does this trial involve?
- Intervention group: a baseline assessment and another assessment after the 6 month intervention period.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Wearable / at-home monitoring (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.