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

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

Conditions

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

Interventions

BEHAVIORAL

Increase 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.).

Sponsors & Collaborators

• Stichting ParkinsonNL

  collaborator UNKNOWN

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Michael J. Fox Foundation for Parkinson's Research

  collaborator OTHER

• Parkinson's UK

  collaborator OTHER

• Cure Parkinson's

  collaborator OTHER

• Edmond J. Safra Foundation

  collaborator UNKNOWN

• Davis Phinney Foundation

  collaborator OTHER

• Donders Centre for Cognitive Neuroimaging

  collaborator OTHER

• Anne Wojcicki Foundation

  collaborator UNKNOWN

• Sleep Medicine Centre Kempenhaeghe

  collaborator OTHER

• Sleep Medicine Centre SEIN

  collaborator UNKNOWN

• Queen Mary University of London

  collaborator OTHER

• 23andMe, Inc.

  collaborator INDUSTRY

• Parkinsons Progression Markers Initiative (PPMI)

  collaborator UNKNOWN

• Massachusetts General Hospital

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• IJsfontein B.V., Netherlands

  collaborator UNKNOWN

• Hoffmann-La Roche

  collaborator INDUSTRY

• Erasmus Medical Center

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• University of Plymouth

  collaborator OTHER

• University of Luebeck

  collaborator OTHER

• McGill University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Sirwan KL Darweesh, PhD · Radboudumc Department of Neurology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-15

Primary Completion

2027-12-01

Completion

2027-12-01

Countries

• Netherlands

Study Locations