Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
Recruiting · NCT06193252 · 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 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
Who can take part
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
Where it is running
1 location listed.
- Radboud University Medical Center - Nijmegen, Gelderland, Netherlands