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
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 2 years and 7 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.