Status:
RECRUITING
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Stichting ParkinsonNL
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Parkinson Disease
Prodromal Stage
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with is...
Detailed Description
Rationale: Parkinson's Disease (PD) is the fastest growing neurodegenerative disease. Exercise beneficially effects motor symptoms and neuroplasticity in people with PD. However, disease-slowing inter...
Eligibility Criteria
Inclusion
- previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)
- able to understand the Dutch language
- being able to walk independently inside the home without the use of a walking aid
- Not in a high physical activity range during the 4-week eligibility and baseline period
- in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.
Exclusion
- clinically diagnosed or self-reported diagnosis neurodegenerative disease;
- self-reported weekly falls in the previous 3 months;
- dexterity problems or cognitive impairments hampering smartphone use;
- if they do not wish to be informed about an increased risk of developing diseases associated with iRBD
- if individual is not community-dwelling
- Exclusion criteria for MRI only:
- history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery
- claustrophobia
- implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)
- metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters
- pregnancy
- fear for incidental finding
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06193252
Start Date
January 15 2024
End Date
December 1 2027
Last Update
June 3 2025
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA