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

ConditionsParkinson Disease Prodromal Stage Neurodegenerative Diseases Basal Ganglia Diseases Central Nervous System Diseases Synucleinopathies Nervous System Diseases Cerebral Disorder Brain Diseases Parkinsonian Disorders Genetic Predisposition

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorRadboud University Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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).

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Large increase in step count and moderate to vigorous physical activity relative to baseline level.Experimental treatment 1 intervention

Group B: Small increase in step count and moderate to vigorous physical activity relative to baseline level.Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in composite prodromal load score

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

Time frame

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.

Time frame