NCT06193252 Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
| NCT ID | NCT06193252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2027-12-01 |
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 110 participants in total. It began in 2024-01-15 with a primary completion date of 2027-12-01.
⚠ 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 to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months). 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. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we 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 States and United Kingdom are currently in preparation (Slow-SPEED). 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: * previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3) * able to understand the Dutch language * being able to walk independently inside the home without the use of a walking aid * Not in a high physical activity range during the 4-week eligibility and baseline period * in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application. Exclusion Criteria: * clinically diagnosed or self-reported diagnosis neurodegenerative disease; * self-reported weekly falls in the previous 3 months; * dexterity problems or cognitive impairments hampering smartphone use; * if they do not wish to be informed about an increased risk of developing diseases associated with iRBD * if individual is not community-dwelling Exclusion criteria for MRI only: * history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery * claustrophobia * implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator) * metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters * pregnancy * fear for incidental finding
Contact & Investigator
Sirwan KL Darweesh, PhD
PRINCIPAL INVESTIGATOR
Radboudumc Department of Neurology
Frequently Asked Questions
Who can join the NCT06193252 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 NCT06193252 currently recruiting?
Yes, NCT06193252 is actively recruiting participants. Contact the research team at thomas.oosterhof@radboudumc.nl for enrollment information.
Where is the NCT06193252 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT06193252 clinical trial?
NCT06193252 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 110 participants.
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