Parkinson's disease (PD), REM-sleep behaviour disorder (RBD) Parkinson's disease, REM-sleep behaviour disorder
Conditions
Interventions
Participants will be randomized into one of two groups. Both groups will be 
encouraged to gradually increase the volume and intensity of their physical 
activities. Volume will be measured with a smartphone and smartwatch as change 
in step count relative to their own baseline step count (<
10,000). Intensity will 
be measured as change in the amount of minutes in which >
64% heart rate of 
their maximum heart rate is exerted relative to their own baseline count. The 
target step count and intensity will be a large relative increase (by 100%) for 
the intervention group (N=55). The active control group will get a target step 
count and intensity with a small relative increase (by 10%) (N=55). Treatment 
will be administered remotely using a gamified enhanced app.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: According to the latest C1 research protocol, version 8.0, January 15, 2025previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)61. Criteria A–D must be met: Repeated episodes of sleep related vocalization and/or complex motor behavioursThese behaviours are documented by polysomnography to occur during REM sleep or, based on clinical history of dream enactment, are presumed to occur during REM sleep Polysomnographic recording demonstrates REM sleep without atonia (RWA) The disturbance is not explained more clearly by another sleep disorder, mental disorder, medication, or substance use (the usage of beta-blockers or anti-depressant as possible luxating factor is not excluded)aged 50 years or olderable to understand the Dutch 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)less than an average 10,000 steps/day during the 4-week eligibility and baseline period
Exclusion criteria
Exclusion criteria: According to the latest C1 research protocol, version 8.0, January 15, 20251) clinically diagnosed or self-reported diagnosis neurodegenerative disease; 2) self-reported weekly falls in the previous 3 months; 3) dexterity problems or cognitive impairments hampering smartphone use; 4) if they do not wish to be informed about an increased risk of developing diseases associated with iRBD5) if individual is not community-dwelling6) in possession of one of the following devices: Huawei P8 Lite ; Huawei P9 Lite ; Xiaomi Mi 6 ; Huawei P20 Lite (Fitbit is incompatible)Exclusion for MRI brain-imaging only:7) history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large archnoid cysts) or brain surgery8) claustrophobia9) implanted electrical devices (i.e. pacemaker, DBS, neurostimulator)10) metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part)11) pregnancy12) any other exclusion as per Donders Centre for Cognitive Neuroimaging MRI screening form (supplement F1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the within subject change (from baseline to 2-year follow-up) in number of steps between the treatment- and active control arm, measured with the participants' smartphone and smartwatch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be longitudinal change in measures of physical fitness, prodromal motor and non-motor features of PD, biological mediators for prodromal disease progression (blood: neuroinflammation, neurodegeneration, pathological protein spread, growth factors and ageing mechanisms, brain imaging markers of global and region-specific atrophy and neuroplasticity). Furthermore, we will assess completeness of remote digital biomarker assessments in both groups combined and feasibility. We will explore the incidence of clinically manifest PD in both treatment arms, acknowledging that only few participants may reach this endpoint during this 2-year study. Finally, we will conduct sensitivity analyses on gene specific mutations. | — |
Countries
Netherlands
Contacts
Public ContactT.H. Oosterhof
Radboud Universitair Medisch Centrum
Outcome results
None listed