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

RecruitingNAAges 50 Years - anyAllRadboud University Medical Center
NCT06193252 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 m

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📋 Eligibility rules (as published)
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
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What it tests

  • Increase of physical activity volume and intensity with the use of a motivational smartphone application
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Where

1 site
Radboud University Medical Center
Nijmegen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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