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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

1) previously diagnosed with iRBD meeting the following criteria according to
the International Classification of Sleep Disorders (ICSD-3)59. Criteria A-D
must be met:
a. Repeated episodes of sleep related vocalization and/or complex motor
behaviours
b. These 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
c. Polysomnographic recording demonstrates REM sleep without atonia (RWA)
d. 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)
2) Aged 50 years or older
3) able to understand the Dutch language;
4) being able to walk independently inside the home without the use of a
walking aid.
5) equal to or less than 120 minutes of sports/outdoor activities per day
(question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
6) less than an average 7,000 steps/day during the 4-week eligibility and
baseline period
7) In possession of a suitable smartphone (screen size minimum 4.6 inch),
(Android version 9 or iOS version 15 or newer)

Exclusion Criteria

1) 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 iRBD
5) if individual is not community dwelling

Regarding the MRI brain-imaging:
6) history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic
defects, large
archnoid cysts) or brain surgery
7) claustrophobia
8) implanted electrical devices (i.e. pacemaker, DBS, neurostimulator)
9) metal implants (such as prosthetics, ossicle prosthesis, metal plates or
other non-removable metal part)
10) pregnancy
11) any other exclusion as per Donders Centre for Cognitive Neuroimaging MRI
screening form

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the longitudinal change (from baseline to 2-year<br /><br>follow-up) in number of steps between the treatment- and active control arm,<br /><br>measured with the participants* smartphone and smartwatch. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be longitudinal change in measures of physical fitness,<br /><br>prodromal motor and non-motor features of PD, biological mediators for<br /><br>prodromal disease progression (blood: neuroinflammation, neurodegeneration,<br /><br>pathological protein spread, growth factors and ageing mechanisms, brain<br /><br>imaging markers of global and region-specific atrophy and neuroplasticity).<br /><br>Furthermore, we will assess completeness of remote digital biomarker<br /><br>assessments in both groups combined and feasibility. We will explore the<br /><br>incidence of clinically manifest PD in both treatment arms, acknowledging that<br /><br>only few participants may reach this endpoint during this 2-year study.<br /><br>Finally, we will conduct sensitivity analyses on gene specific mutations. </p><br>

Related Trials

The Parkinson's Progression Markers Initiative (PPMI)

MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH

Updated 8/28/2012