Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands

Recruiting now · Not applicable

Conditions studied: 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

In brief

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

Key facts

Study ID: NCT06193252
Run by: Radboud University Medical Center
People needed: 110
Starts: 2024-01-15
Expected to finish: 2027-12-01
Last updated by the study team: 2025-06-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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