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.
Age: 50-80 years
Polysomnographically confirmed diagnosis of iRBD
Maximum of 120 minutes of sports/outdoor activities per day
Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase
Relevant cardiovascular diseases
Problems with dexterity or cognitive impairments that make it difficult to use a smartphone
Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study
Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)
Parallel
Increase of physical activity volume and intensity with the use of a motivational smartphone application
BehavioralA motivational smartphone application will be available for all participants using their own smartphone: the Alpha-Fit app, comparable to the SLOW-SPEED app (https://clinicaltrials.gov/study/NCT06993142). The Alpha-Fit app will motivate participants to increase the volume and intensity of their physical activity in daily life over a long period of time (12 months) based on their own baseline levels. Different treatment arms will receive different physical activity goals. The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase of step count and minutes exerting ≥ 64% of maximum heart rate reflecting moderate-to-vigorous physical activity (MVPA) relative to baseline level).
Cognitive Performance: Change in mild cognitive impairment (MCI) in PD Level II Criteria
Change in cognitive performance between the start of the study (baseline) and the time after the intervention (after 12 months of intervention), measured as the global mean of the results from a neuropsychological test battery according to MCI in PD Level II criteria. Executive functions: * semantic word fluency * set-shifting abilities * inhibition * logical thinking Visual cognitive abilities: * spatial perception * working memory performance * processing speed * attention Memory functions: * verbal memory * visuospatial memory Linguistic abilities: * naming semantic * abstract thinking
Motor functions: Change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III
Change in score which ranges from 0 to 108. Higher score indicates greater motor impairment.
Motor functions: Change Perdue-Pegboard-Test
Change in score. Higher scores indicates better manual dexterity and hand coordination.
Motor functions: Change in digital testing outcomes
Change in digital testing assessment, funded by the European Research Council (ERC) (https://cordis.europa.eu/project/id/101169580).
Change in body composition
Change in body composition measured through MRI sequences and bio-electric impedance analysis.
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University Hospital, Bonn
Lead sponsor
Radboud University Medical Center
Collaborator
Medical University Innsbruck
Collaborator
IJsfontein B.V., Netherlands
Collaborator
Synaptikon GmbH
Collaborator
Parkinson Stiftung
Collaborator
