Actively Recruiting
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
Led by Radboud University Medical Center · Updated on 2025-06-03
110
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
S
Stichting ParkinsonNL
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously diagnosed with isolated REM sleep behavior disorder (iRBD) according to ICSD-3 criteria
- Able to understand the Dutch language
- Able to walk independently inside the home without a walking aid
- Not in a high physical activity range during the 4-week eligibility and baseline period
- Own a suitable smartphone compatible with the Slow-SPEED app, Fitbit app, and Roche PD Research Mobile application
You will not qualify if you...
- Clinically diagnosed or self-reported neurodegenerative disease
- Self-reported weekly falls in the previous 3 months
- Dexterity problems or cognitive impairments that prevent smartphone use
- Do not wish to be informed about an increased risk of diseases associated with iRBD
- Not living in the community
- For MRI only: history of epilepsy, structural brain abnormalities, or brain surgery
- Claustrophobia
- Implanted electrical devices like pacemaker, deep-brain stimulator, or neurostimulator
- Metal implants or metal splinters
- Pregnancy
- Fear of incidental findings during MRI
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
Research Team
T
Thomas Oosterhof, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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