Exercise for Early Parkinson's Disease

(Slow-SPEED Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can help individuals with certain genetic markers for early Parkinson's increase their physical activity. The researchers seek to find out if this increase in exercise can slow early signs of Parkinson's. Participants will be divided into groups to increase their daily steps and exercise intensity from their usual levels. This trial suits individuals who know they have specific genetic markers (LRRK2 G2019S or GBA1 N370S) and can walk unaided indoors. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could lead to new ways of managing early Parkinson's.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise intervention is safe for individuals with a genetic mutation linked to Parkinson's disease?

Research has shown that using a smartphone app to increase physical activity is safe for people with Parkinson's disease. One study found that exercising at home with an app was not only feasible but also safe, and it appeared to improve symptoms like movement and thinking skills. Another study examined an app designed to boost physical activity in people with Parkinson's and also found it could be safely used to increase activity levels.

Overall, evidence indicates that using a smartphone app to promote physical activity is safe and well-tolerated for people with Parkinson's disease. These studies reported no serious side effects, making this approach a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how increasing physical activity can benefit individuals with early Parkinson's disease using a motivational smartphone app. Traditional treatments for Parkinson's often focus on medication to manage symptoms, but this approach emphasizes lifestyle changes that could have a lasting impact. The trial looks at different levels of activity increase, which could offer insights into how much exercise is needed to see real benefits. By leveraging technology to motivate and track progress, this method could make it easier for people to incorporate beneficial exercise into their daily routines, potentially slowing disease progression in a way that medication alone might not achieve.

What evidence suggests that increasing physical activity with a smartphone app might be effective for early Parkinson's disease?

This trial will compare different levels of physical activity increase for individuals with early Parkinson's Disease (PD) using a motivational smartphone application. Research has shown that moderate to high-intensity aerobic exercise can help with movement problems in PD and might even slow its progression. Studies have found that regular activity links to better health outcomes in PD. Exercising independently can also alleviate symptoms in the early and middle stages of PD. Digital tools, such as smartphone apps, effectively encourage exercise and are well-received by people with PD. Overall, increasing physical activity with a motivational app could effectively manage early signs of PD. ^{6 7 8 9 10}

Who Is on the Research Team?

Sirwan KL Darweesh, PhD

Principal Investigator

Radboudumc Department of Neurology

Are You a Good Fit for This Trial?

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

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

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

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)

Dexterity problems or cognitive impairments hampering smartphone use

Not community-dwelling

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10200135/

Clinical Trial Highlights – Interventions Promoting Physical ... Most evidence favors moderate- to high-intensity aerobic exercise for its positive effects on motor symptoms as well as disease modifying potential.

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000013218

Long-term Effect of Regular Physical Activity and Exercise ... In the long term, the maintenance of high regular physical activity levels and exercise habits was robustly associated with better clinical course of PD.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380294/

Digital Intervention Promoting Physical Activity in People ... The KEEP intervention was feasible and acceptable in people newly diagnosed with PD. A larger trial is needed to assess intervention efficacy.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167494323002376

Self-directed physical activity interventions for motor ... Self-directed physical activity (SDPA) has been found in previous research to alleviate some of the symptoms of early and mid-stage Parkinson's disease (PD) ...

5. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02892-2

Interventions for promoting physical activity in people with ... There is increasing evidence to suggest that physical activity can slow Parkinson's progression. There is also increasing interest in non- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10338039/

Home-based exercise training by using a smartphone app ... The home-based training was feasible, safe and seems to positively act on PD-related symptoms, mobility, and cognition in patients with mild to moderate stage ...

7. journals.lww.com journals.lww.com/jnpt/fulltext/2025/04000/promoting_physical_activity_in_people_with.3.aspx

Promoting Physical Activity in People With Parkinson's... To increase physical activity in people with PD, we developed a motivational application (STEPWISE app) in co-creation with people with PD. The app was ...

8. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/counter/pdf/10.1186/s12883-023-03355-8.pdf?utm_source=consensus

The STEPWISE study Discussion This trial evaluates the potential of a smartphone-based intervention to increase activity levels in people with PD. We envision that motivational ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06993142

Slow-SPEED: Slowing Parkinson's Early Through Exercise ... The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39763021/

Promoting Physical Activity in People With Parkinson's ... We investigated the feasibility (ability to increase step counts) and usability of a behavioral intervention using a motivational smartphone application.