Increase of physical activity volu… for Parkinson's (Slow-SPEED-NL, NCT06193252)
Slow Parkinson progression through exercise
- Trial ID
- NCT06193252
- Official Title
- Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
- Study Acronym
- Slow-SPEED-NL
- 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?
- 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 trial is estimated to last approximately 3 years and 11 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.