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

Summary

The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation.

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. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, the investigators 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 Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). 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
• Basal Ganglia Diseases
• Central Nervous System Diseases
• Synucleinopathies
• Nervous System Diseases
• Cerebral Disorder
• Brain Diseases
• Parkinsonian Disorders
• Genetic Predisposition

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 moderate-to-vigorous physical activity (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

• 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

• Donders Centre for Cognitive Neuroimaging

  collaborator OTHER

• Parkinson's Foundation

  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

2025-07-01

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• United States
• Netherlands

Study Locations