Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage
Recruiting · NCT06993142 · Interventional (participants receive a specific treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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 take part
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed across 1 US state.
- University of Rochester Center for Health and Technology (CHeT) - Rochester, New York, United States
- Radboud University Medical Center - Nijmegen, Gelderland, Netherlands