NCT06193252Recruiting
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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 isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months). Participants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 21 Dec 2023
- Start date
- 15 Jan 2024
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT06193252
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 15 Jan 2024 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- self-reported weekly falls in the previous 3 months;
- metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters
Other illness
- clinically diagnosed or self-reported diagnosis neurodegenerative disease;
- if they do not wish to be informed about an increased risk of developing diseases associated with iRBD
- history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery
Other
- dexterity problems or cognitive impairments hampering smartphone use;
- if individual is not community-dwelling
- claustrophobia
- implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)
- pregnancy
- fear for incidental finding
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
Related publications
- Slow-SPEED: protocol for three randomised trials of remotely delivered exercise to prevent Parkinson's disease.NPJ Parkinsons Dis · 2026 · PMID 42448717
- Towards biomarker-based diagnosis of Parkinson disease.Nat Rev Neurol · 2026 · PMID 41688680
This page is information, not medical advice. Discuss any trial with your doctor.