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

The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation. 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. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, the investigators 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 Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). 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

NCT Number	NCT06993142
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, 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, Donders Centre for Cognitive Neuroimaging, Parkinson's Foundation
Conditions	Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Cerebral Disorder +3 more
Enrollment	600 participants
Start Date	2025-07-01
Primary Completion	2029-06-30 (estimated)
Study Completion	2029-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-03