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Search / Trial NCT06193252

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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Dec 21, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Physical Activity Prevention Remote Mobile Health (M Health) Feasibility Exercise Digital Biomarker Blood Imaging Mri Motivational Application Walking Parkinson Disease Prodromal

ClinConnect Summary

The Slow-SPEED-NL trial is studying whether a smartphone app can help people with a condition called isolated REM sleep behavior disorder (iRBD) increase their physical activity levels over 24 months. This trial focuses on encouraging participants to walk more and exercise at a certain intensity, using the app to provide motivation and track their progress. Participants will be monitored with a Fitbit smartwatch to see how their step count and exercise intensity improve over time. The trial aims to gather valuable information that could help better understand the early stages of Parkinson's disease.

To be eligible for the trial, participants should have been diagnosed with iRBD, understand Dutch, and be able to walk independently at home without assistance. They should also be taking fewer than 10,000 steps a day on average and have a compatible smartphone. Throughout the study, participants will work towards increasing their daily activity and will be supported through the app. It's important to note that individuals with certain medical conditions or those who have experienced recent falls are not eligible to join. This study is not just limited to the Netherlands; it is part of a larger international effort to explore how exercise can benefit those at risk of developing Parkinson's disease.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)
  • able to understand the Dutch language
  • being able to walk independently inside the home without the use of a walking aid
  • Not in a high physical activity range during the 4-week eligibility and baseline period
  • in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.
  • Exclusion Criteria:
  • clinically diagnosed or self-reported diagnosis neurodegenerative disease;
  • self-reported weekly falls in the previous 3 months;
  • dexterity problems or cognitive impairments hampering smartphone use;
  • if they do not wish to be informed about an increased risk of developing diseases associated with iRBD
  • if individual is not community-dwelling
  • Exclusion criteria for MRI only:
  • history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery
  • claustrophobia
  • implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)
  • metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters
  • pregnancy
  • fear for incidental finding

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

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