Actively Recruiting
Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
Led by University Hospital, Bonn · Updated on 2026-01-16
130
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bonn
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions. The aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year. Eighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the "Deutsches Zentrum für Neurodegenerative Erkrankungen" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https://clinicaltrials.gov/study/NCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.
CONDITIONS
Official Title
Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years
- Polysomnographically confirmed diagnosis of isolated REM sleep behavior disorder (iRBD) for iRBD group
- Maximum of 120 minutes of sports or outdoor activities per day
- Average less than 10,000 steps per day during the 4-week eligibility and baseline phase
- Basic skills in using a smartphone
- Sufficient knowledge of German (native speaker or C1/C2 level)
- Ownership of a suitable smartphone with a minimum 4.6-inch screen running Android 9 or iOS 15 or newer
- Consent to be informed of any additional findings
You will not qualify if you...
- Relevant cardiovascular diseases
- Problems with dexterity or cognitive impairments that prevent effective smartphone use
- Cognitive impairments limiting ability to provide informed consent
- Ownership of incompatible devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite
- For healthy controls: clinically diagnosed isolated REM sleep behavior disorder (iRBD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital of Bonn
Bonn, North Rhine West-Falia, Germany, 53111
Actively Recruiting
Research Team
M
Martin M Rodemann
CONTACT
E
Emily L Fitzgibbon, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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