NCT06993142 · Radboud University Medical Center
Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage
(Slow-SPEED)
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).
View original scientific 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).
Interventions
BEHAVIORAL
Increase of physical activity volume and intensity with the use of a motivational smartphone application
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).
Primary outcome measures
Change in composite prodromal load score
Time frame: From inclusion (week 0) to the end of treatment (week 156)
Change in prodromal load score, comprised of digital biomarkers for prodromal symptoms. The score is currently under development.
Mean change in step count per day
Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment)
Mean change in step count per day as measured continuously with a smartwatch. Mean steps per day will be calculated from 4-week periods. Higher positive change in step count indicate more volume of physical activity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, New York
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
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations