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Search / Trial NCT06993142

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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · May 19, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Physical Activity Prevention Remote Mobile Health (M Health) Feasibility Exercise Digital Biomarker Motivational Application Walking Parkinson Disease Prodromal Lrrk2 Gba1 Genetic Smartwatch

ClinConnect Summary

The Slow-SPEED trial is studying whether a smartphone app can help people with specific genetic mutations (LRRK2 G2019S or GBA1 N370S) increase their daily physical activity over two years. The goal is to see if exercising more can slow down the early signs of Parkinson's disease for those who may be at risk. Participants will use the app to track and encourage themselves to walk more and exercise at a certain heart rate, aiming to improve their overall fitness and gather important health data.

To be eligible for this trial, participants need to be at least 50 years old, have one of the identified genetic mutations, and be able to walk independently without help. They'll also need to own a compatible smartphone and currently walk less than 10,000 steps a day. During the study, participants can expect to receive support through the app and will be monitored for changes in their health related to physical activity. This trial is still in the planning stages and has not started recruiting participants yet, but it aims to help researchers understand how exercise can impact the early stages of Parkinson's disease.

Gender

ALL

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)

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Nijmegen, Gelderland, Netherlands

Rochester, New York, United States

Patients applied

0 patients applied

Trial Officials

Sirwan KL Darweesh, PhD

Principal Investigator

Radboudumc Department of Neurology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported