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

Sponsor: Radboud University Medical Center • ClinicalTrials.gov ID: NCT06993142

Registry updated: 2026-10-15

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Description

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

Interventions

Increase of physical activity volume and intensity with the use of a motivational smartphone application (Behavioral)
A motivational smartphone application will be available for all participants using their own smartphone: the Slow-SPEED app. The Slow-SPEED app will motivate participants to increase the volume and intensity of their physical activity in daily life over a long period of time (2 years) based on their own baseline levels. Different treatment arms will receive different physical activity goals. The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase of step count and minutes exerting ≥ 64% of maximum heart rate reflecting moderate-to-vigorous physical activity (MVPA) relative to baseline level).

Eligibility criteria

Inclusion criteria 1. previously identified LRRK2 G2019S or GBA N370S variant based on genotyping 2. aged 50 years or older 3. able to understand the English language 4. being able to walk independently inside the home without the use of a walking aid 5. in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer) 6. Not in a high physical activity range during the 4-week eligibility and baseline period Exclusion criteria 1. clinically diagnosed or self-reported diagnosis neurodegenerative disease 2. self-reported falls of three or more per year 3. dexterity problems or cognitive impairments hampering smartphone use 4. 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 5. if individual is not community-dwelling 6. in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)

Conditions

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

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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