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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Thomas Oosterhof, MSc
thomas.oosterhof@radboudumc.nl
0031631647857
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 110
Treatments
Experimental: Intervention
Large proportional increase in step count and minutes exerting moderate to vigorous physical activity (MVPA) relative to baseline level.
Active_comparator: Active control
Small proportional increase in step count and minute exerting moderate to vigorous physical activity (MVPA) relative to baseline level.
Related Therapeutic Areas
Sponsors
Collaborators: University of Rochester, Parkinson's UK, IJsfontein B.V., Netherlands, Massachusetts General Hospital, University of Luebeck, Davis Phinney Foundation, Michael J. Fox Foundation for Parkinson's Research, University of Pittsburgh, Sleep Medicine Centre Kempenhaeghe, Sleep Medicine Centre SEIN, University of Bristol, Erasmus Medical Center, University of Plymouth, ZonMw: The Netherlands Organisation for Health Research and Development, Stichting ParkinsonNL, Hoffmann-La Roche, Queen Mary University of London, Parkinsons Progression Markers Initiative (PPMI), 23andMe, Inc., Harvard School of Public Health (HSPH), McGill University, Anne Wojcicki Foundation, Cure Parkinson's, University of Illinois at Chicago, Edmond J. Safra Foundation, Donders Centre for Cognitive Neuroimaging
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov