Slow Parkinson progression through exercise
- Trial ID
- NCT06193252
- Official Title
- Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
- Goal
- Slow Parkinson progression through exercise
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Radboud University Medical Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 110 participants
- Conditions
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Parkinsonian Disorders, REM Sleep Behavior Disorder, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Cerebral Disorder, Brain Diseases
- Interventions
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
Summary For Families
The goal is to slow or delay the shift from idiopathic REM sleep behavior disorder into Parkinson's disease and related synucleinopathies by boosting early brain resilience. The approach is a non-drug exercise program delivered through a motivational smartphone app with Fitbit monitoring that gradually increases the volume and intensity of physical activity, the idea being that more and stronger aerobic and movement training can improve blood flow, lower inflammation, and support neural circuits that help preserve motor and cognitive function, and because it is a lifestyle intervention it does not involve medications or interact with levodopa. They are enrolling Dutch-speaking adults aged 50 and older who have iRBD, can walk independently, are not already in a high activity range, own a compatible smartphone, live in the community, and do not have a diagnosed neurodegenerative disease, frequent weekly falls, or problems using a phone.
Locations
- Radboud University Medical Center, Nijmegen, Gelderland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Increase of physical activity volume and intensity with the use of a motivational smartphone application. The goal is to slow or delay the shift from idiopathic REM sleep behavior disorder into Parkinson's disease and related synucleinopathies by boosting early brain resilience. The approach is a non-drug exercise program delivered through a motivational smartphone app with Fitbit monitoring that gradually increases the volume and intensity of physical activity, the idea being that more and stronger aerobic and movement training can improve blood flow, lower inflammation, and support neural circuits that help preserve motor and cognitive function, and because it is a lifestyle intervention it does not involve medications or interact with levodopa. They are enrolling Dutch-speaking adults aged 50 and older who have iRBD, can walk independently, are not already in a high activity range, own a compatible smartphone, live in the community, and do not have a diagnosed neurodegenerative disease, frequent weekly falls, or problems using a phone.
- Who can participate?
- Participants must be at least 50 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 trial is estimated to last approximately 3 years and 11 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.