Exercise for Early Parkinson's Disease

(Slow-SPEED Trial)

Recruiting at 1 trial location

Overseen By Thomas Oosterhof, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radboud University Medical Center

Disqualifiers: Neurodegenerative disease, Falls, Dexterity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 156 weeks

600 Participants Needed

Trial Summary

What is the purpose of 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

Research Team

Sirwan KL Darweesh, PhD

Principal Investigator

Radboudumc Department of Neurology

Eligibility Criteria

This trial is for individuals with LRRK2 G2019S or GBA1 N370S genetic mutations, which are linked to Parkinson's disease. Participants should be willing to use a smartphone app designed to motivate increased physical activity over 24 months.

Inclusion Criteria

I can walk by myself at home without needing any help.

In possession of a suitable smartphone (screen size minimum 4.6 inch, Android version 9 or iOS version 15 or newer)

I have a LRRK2 G2019S or GBA N370S genetic mutation.

Exclusion Criteria

In possession of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (Fitbit is incompatible)

I don't know and don't want to know my risk for diseases linked to LRRK2 or GBA1.

Not community-dwelling

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Remote assessment

Baseline Assessment

Baseline physical activity levels are determined over a 4-week period using a smartwatch

4 weeks

Remote monitoring

Treatment

Participants are randomized and motivated to increase physical activity using a smartphone app over a long-term period

156 weeks

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Remote assessment

Treatment Details

Interventions

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

Trial Overview The study tests if a motivational smartphone app can boost physical activity in people at risk of developing Parkinson's due to specific genetic mutations. It measures the impact on early signs of the disease and overall fitness levels using digital biomarkers.

Participant Groups

Group I: Large increase in step count and moderate to vigorous physical activity relative to baseline level. Experimental Treatment 1 Intervention

Group II: Small increase in step count and moderate to vigorous physical activity relative to baseline level. Active Control 1 Intervention

Who Is Running the Clinical Trial?

Radboud University Medical Center

Lead Sponsor

Trials

1,203

Recruited

1,157,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Trials

422

Recruited

381,000+

Hoffmann-La Roche

Industry Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Parkinson's UK

Collaborator

Trials

6

Recruited

4,900+

Cure Parkinson's

Collaborator

Trials

6

Recruited

5,200+

Davis Phinney Foundation

Collaborator

Trials

5

Recruited

490+

Erasmus Medical Center

Collaborator

Trials

742

Recruited

2,156,000+

University of Bristol

Collaborator

Trials

114

Recruited

25,030,000+