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

NCT06993142 | Not Yet Recruiting

• 2 other identifiers: IRB ID: 13495PF-Trail-1421986
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 2

Brief 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; Genetic Predisposition; Parkinsonian Disorders

Keywords

Physical activity; Prevention; Remote; Mobile Health (mHealth); Feasibility; Exercise; Digital biomarker; Motivational application; Walking; Parkinson Disease; Prodromal; LRRK2; GBA1; Genetic; Smartwatch

Outcome Measures

Primary Outcomes (2)

• Change in composite prodromal load score

  Change in prodromal load score, comprised of digital biomarkers for prodromal symptoms. The score is currently under development.

  From inclusion (week 0) to the end of treatment (week 156)

• 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.

  All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment)

Secondary Outcomes (32)

• Change in moderate to vigorous physical activity (MVPA) per day

  All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment)

• Change in resting heart rate (physical fitness)

  All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment)

• Change in heart rate variability (physical fitness & autonomic function)

  All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment)

• Change in VO2max (physical fitness)

  All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment)

• Change in anxiety and depression (HADS)

  Week 0 (baseline), week 52 (1 year), week 104 (2 years), week 156 (end of treatment)

Study Arms (2)

Large increase in step count and moderate to vigorous physical activity relative to baseline level.

EXPERIMENTAL

Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application

Small increase in step count and moderate to vigorous physical activity relative to baseline level.

ACTIVE COMPARATOR

Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application

Interventions

Increase of physical activity volume and intensity with the use of a motivational smartphone application BEHAVIORAL

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).

Large increase in step count and moderate to vigorous physical activity relative to baseline level.; Small increase in step count and moderate to vigorous physical activity relative to baseline level.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previously identified LRRK2 G2019S or GBA N370S variant based on genotyping
• aged 50 years or older
• able to understand the English language
• being able to walk independently inside the home without the use of a walking aid
• in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer)
• Not in a high physical activity range during the 4-week eligibility and baseline period

You may not qualify if:

• clinically diagnosed or self-reported diagnosis neurodegenerative disease
• self-reported falls of three or more per year
• dexterity problems or cognitive impairments hampering smartphone use
• if they are not aware of and do not wish to be informed about an increased risk of developing diseases associated with the LRRK2 or GBA1 risk variant
• if individual is not community-dwelling
• in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• 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
• 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
• Donders Centre for Cognitive Neuroimaging: collaborator
• Parkinson's Foundation: collaborator

Study Sites (2)

University of Rochester Center for Health and Technology (CHeT)

Rochester, New York, 14642, United States

Location

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease; Prodromal Symptoms; Neurodegenerative Diseases; Basal Ganglia Diseases; Central Nervous System Diseases; Synucleinopathies; Nervous System Diseases; Brain Diseases; Parkinsonian Disorders; Genetic Predisposition to Disease; Motor Activity

Condition Hierarchy (Ancestors)

Movement Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Behavior

Study Officials

• Sirwan KL Darweesh, PhD

  Radboudumc Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Oosterhof, MSc

CONTACT

0031631647857; thomas.oosterhof@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Double-blind randomized controlled trial

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We will make relevant anonymised data available in a database after publication of the main results of our trial.
• Access Criteria: Researchers who are interested in re-use of the data are asked to contact the central contact person for permission.

Locations

NL (1); US (1)