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New treatment option for Parkinson Disease
Official title Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
ClinicalTrials.gov ID: NCT06193252
What this study is testing
- What it's testing
- The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months). Participants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.