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

Starting soon · Not applicable

Conditions studied: Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Cerebral Disorder, Brain Diseases, Parkinsonian Disorders, Genetic Predisposition

In brief

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

Key facts

Study ID: NCT06993142
Run by: Radboud University Medical Center
People needed: 600
Starts: 2025-07-01
Expected to finish: 2029-06-30
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 identified LRRK2 G2019S or GBA N370S variant based on genotyping
aged 50 years or older
able to understand the English language
being able to walk independently inside the home without the use of a walking aid
in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer)
Not in a high physical activity range during the 4-week eligibility and baseline period

You may not qualify if…

clinically diagnosed or self-reported diagnosis neurodegenerative disease
self-reported falls of three or more per year
dexterity problems or cognitive impairments hampering smartphone use
if they are not aware of and do not wish to be informed about an increased risk of developing diseases associated with the LRRK2 or GBA1 risk variant
if individual is not community-dwelling
in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)

Where it is running

University of Rochester Center for Health and Technology (CHeT) — Rochester, New York, United States
Radboud University Medical Center — Nijmegen, Gelderland, Netherlands

Full record on ClinicalTrials.gov

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