NCT06993142 Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage
| NCT ID | NCT06993142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-09-01 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Sirwan KL Darweesh, PhD
PRINCIPAL INVESTIGATOR
Radboudumc Department of Neurology
Frequently Asked Questions
Who can join the NCT06993142 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06993142 currently recruiting?
Yes, NCT06993142 is actively recruiting participants. Contact the research team at thomas.oosterhof@radboudumc.nl for enrollment information.
Where is the NCT06993142 trial being conducted?
This trial is being conducted at Rochester, United States, Nijmegen, Netherlands.
Who is sponsoring the NCT06993142 clinical trial?
NCT06993142 is sponsored by Radboud University Medical Center. The principal investigator is Sirwan KL Darweesh, PhD at Radboudumc Department of Neurology. The trial plans to enroll 600 participants.
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