Recruiting

Exercise Intervention

Sponsor:

Radboud University Medical Center

Code:

NCT06993142

Conditions

Parkinson Disease

Prodromal Stage

Neurodegenerative Diseases

Basal Ganglia Diseases

Central Nervous System Diseases

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06993142

Start date

Sep 1, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion criteria

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

Exclusion criteria

1. clinically diagnosed or self-reported diagnosis neurodegenerative disease
2. self-reported falls of three or more per year
3. dexterity problems or cognitive impairments hampering smartphone use
4. 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
5. if individual is not community-dwelling
6. in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

Interventions

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).

Primary outcome measure

  • Change in composite prodromal load score [ Time Frame: From inclusion (week 0) to the end of treatment (week 156) ]
  • Mean change in step count per day [ Time Frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 152 until 156 (end of treatment) ]

Central Contacts and Locations

Central contacts

Thomas Oosterhof, MSc

0031631647857thomas.oosterhof@radboudumc.nl

Locations

University of Rochester Center for Health and Technology (CHeT)

Recruiting

Rochester, New York, United States, 14642

Contacts

Karen Clark

585-275-7311karen.clark@chet.rochester.edu

More Information

Sponsor

Radboud University Medical Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Radboud University Medical Center on 2026-08-27.