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NCT06193252 · ClinicalTrials.gov record · last posted 2026-08-27

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

Study acronym: Slow-SPEED-NL
StatusRecruiting
PhaseNot applicable
Started2024-01-15
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from the ClinicalTrials.gov record
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

Protocol amendment history 2 changes detected by DataLookout

2026-08-28
Primary completion pushed: 2027-12-01 → 2028-12-01
2026-08-28
Completion pushed: 2027-12-01 → 2028-12-01
Trial Details
NCT Number NCT06193252
Lead Sponsor Radboud University Medical Center
Collaborators: Stichting ParkinsonNL, ZonMw: The Netherlands Organisation for Health Research and Development, Michael J. Fox Foundation for Parkinson's Research, Parkinson's UK, Cure Parkinson's, Edmond J. Safra Foundation, Davis Phinney Foundation, Donders Centre for Cognitive Neuroimaging, Anne Wojcicki Foundation, Sleep Medicine Centre Kempenhaeghe, Sleep Medicine Centre SEIN, Queen Mary University of London, 23andMe, Inc., Parkinsons Progression Markers Initiative (PPMI), Massachusetts General Hospital, Harvard School of Public Health (HSPH), IJsfontein B.V., Netherlands, Hoffmann-La Roche, Erasmus Medical Center, University of Illinois at Chicago, University of Rochester, University of Bristol, University of Plymouth, University of Luebeck, McGill University, University of Pittsburgh
Conditions Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Parkinsonian Disorders, REM Sleep Behavior Disorder, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies +3 more
Enrollment 110 participants
Start Date 2024-01-15
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-27