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
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
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
Parallel
Increase of physical activity volume and intensity with the use of a motivational smartphone application
BehavioralA 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.).
Mean change in step count per day
Mean change in step count per day as measured continuously with a smartwatch. Mean steps per day will be calculated from 4-week periods. Higher positive change in step count indicate more volume of physical activity.
Change in moderate to vigorous physical activity (MVPA) per day
Change in number of minutes exerting (minimally) ≥ 64% of maximum heart rate, reflecting moderate intense physical activity, measured continuously using a smartwatch. Mean minutes per day will be calculated from 4-week periods. Higher positive change in minutes of MVPA indicate more aerobic physical activity.
Change in resting heart rate (physical fitness)
Change in resting heart rate per day as measured continuously with a smartwatch. Mean resting heart rate per day will be calculated from 4-week periods. Higher negative change (i.e. lower resting heart rate) indicate better function.
Change in heart rate variability (physical fitness)
Change in heart rate variability in Root Mean Square of Successive Differences (RMSSD) measured every 5 minutes with a smartwatch. Mean RMSSD per day will be calculated from 4-week periods. Higher positive change in RMSSD indicate better function.
Change in blood pressure (physical fitness)
Change from baseline (week 0) blood pressure in mmHg assessed by a sphygmomanometer at follow-up (week 104). Lower scores indicate better function.
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Radboud University Medical Center
Lead sponsor
Stichting ParkinsonNL
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Parkinson's UK
Collaborator
Cure Parkinson's
Collaborator
Edmond J. Safra Foundation
Collaborator
Davis Phinney Foundation
Collaborator
Donders Centre for Cognitive Neuroimaging
Collaborator
Anne Wojcicki Foundation
Collaborator
Sleep Medicine Centre Kempenhaeghe
Collaborator
Sleep Medicine Centre SEIN
Collaborator
Queen Mary University of London
Collaborator
23andMe, Inc.
Collaborator
Parkinsons Progression Markers Initiative (PPMI)
Collaborator
Massachusetts General Hospital
Collaborator
Harvard School of Public Health (HSPH)
Collaborator
IJsfontein B.V., Netherlands
Collaborator
Hoffmann-La Roche
Collaborator
Erasmus Medical Center
Collaborator
University of Illinois at Chicago
Collaborator
University of Rochester
Collaborator
University of Bristol
Collaborator
University of Plymouth
Collaborator
University of Luebeck
Collaborator
McGill University
Collaborator
University of Pittsburgh
Collaborator
