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

Part of paid clinical trials in Rochester, New York.

Sponsor
Radboud University Medical Center
Study ID
NCT06993142
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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

Key Dates

Start date
Jul 1, 2025
Status verified
May 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Change in composite prodromal load score [ Time Frame: From inclusion (week 0) to the end of treatment (week 156) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Center for Health and Technology (CHeT)RochesterNew York14642
Karen Clark
[email protected]
585-275-7311
Ruth Schneider, PhD (SUB_INVESTIGATOR)

Find similar trials in Rochester, NY

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Rochester Center for Health and Technology (CHeT)· Rochester, NY

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