RecruitingNot ApplicableNCT06193252

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

Sponsor

Radboud University Medical Center

Enrollment

110 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Brain Diseases Central Nervous System Diseases Parkinson Disease Nervous System Diseases Neurodegenerative Diseases Synucleinopathies REM Sleep Behavior Disorder Parkinsonian Disorders Basal Ganglia Diseases Prodromal Stage Cerebral Disorder

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

Min Age: 50 Years

Inclusion Criteria5

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 Criteria11

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
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

Interventions

BEHAVIORALIncrease of physical activity volume and intensity with the use of a motivational smartphone application

A motivational smartphone application will be available for all participants using their own smartphone: the Slow-SPEED app. The Slow-SPEED app will motivate participants to increase the volume and intensity of their physical activity in daily life over a long period of time (2 years) based on their own baseline levels. Different treatment arms will receive different physical activity goals. The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase of step count and minutes exerting ≥ 64% of maximum heart rate reflecting MVPA relative to baseline level.).