Increasing physical activity in patients at risk of Parkinson's disease using a smartphone app

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the feasibility of a smartphone app designed to enhance the volume and intensity of physical activity in individuals diagnosed with isolated Rapid Eye Movement (REM) sleep behavior disorder, who are at risk of developing Parkinson's disease. Over a 24-month period, participants will be encouraged to increase their daily step count and exercise intensity based on their individual baseline levels. The app will facilitate motivation and track compliance through digital measures, including step counts recorded by a Fitbit smartwatch. Additionally, the study will explore the retention rates and the effectiveness of remote assessments of prodromal motor and non-motor symptoms associated with Parkinson's disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Radboud University Medical Center
  Nijmegen, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: Sirwan KL Darweesh, PhD — Radboudumc Department of Neurology
• Study coordinator: Thomas Oosterhof, MSc
• Email: thomas.oosterhof@radboudumc.nl
• Phone: 0031631647857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.