Increasing physical activity in patients at risk of Parkinson's disease using a smartphone app
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
This study is testing a smartphone app to help people at risk of Parkinson's disease increase their physical activity and exercise intensity over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06193252 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with isolated REM sleep behavior disorder who can walk independently and are willing to engage with a smartphone app.
Not a fit: Patients with clinically diagnosed neurodegenerative diseases or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help slow the progression of Parkinson's disease in at-risk individuals through increased physical activity.
How similar studies have performed: Other studies have shown promise in using mobile health interventions to promote physical activity, but this specific approach targeting prodromal Parkinson's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen, Gelderland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.