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

Plain Language Summary

Simplified for easier understanding

This study (Slow-SPEED-NL) is testing whether a personalized exercise program using a smartphone app can slow the development of Parkinson's disease in people who have a sleep disorder called REM sleep behavior disorder (iRBD) — a condition that often precedes Parkinson's. **You may be eligible if...** - You have been diagnosed with isolated REM sleep behavior disorder (iRBD) - You can walk independently at home without a walking aid - You understand Dutch - You own a smartphone compatible with the study apps - Your activity level is currently not in the high-activity range **You may NOT be eligible if...** - You already have a diagnosed neurodegenerative disease (e.g., Parkinson's, dementia) - You have fallen repeatedly in the past 3 months - You have severe dexterity or cognitive problems that prevent smartphone use - You do not want to be informed about an increased risk of developing Parkinson's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.).