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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

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

Who to contact

Thomas Oosterhof, MSc · 0031631647857 · thomas.oosterhof@radboudumc.nl

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06993142.