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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a smartphone app can help people exercise more and harder over 24 months. It also looks at whether exercise affects early signs of Parkinson’s disease. It is for adults age 50 or older with the LRRK2 G2019S or GBA1 N370S gene change.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A past gene test found the LRRK2 G2019S or GBA N370S gene change.
  • You are age 50 or older.
  • You can understand English.
  • You can walk inside your home on your own without a walking aid.
  • You have a suitable smartphone with a screen at least 4.6 inches wide diagonally, running Android 9 or newer or iOS 15 or newer.
  • Your physical activity is not in the high range during the first 4 weeks of checks.

Who can't join

  • You have a diagnosed or self-reported disease that causes brain or nerve cells to stop working over time.
  • You report falling 3 or more times per year.
  • Problems with hand movements, thinking, or memory make it hard to use a smartphone.
  • You do not know about the higher disease risks linked to your LRRK2 or GBA1 gene change and do not want to learn about them.
  • You do not live in the community, such as in your own home.
  • You have a Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, or Huawei P20 Lite phone. These phones do not work with Fitbit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY