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Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity

RecruitingNAAges 50 Years - 80 YearsAllUniversity Hospital, Bonn
NCT07324330 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

ฮฑ-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 ฮฑ-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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: iRBD: * 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 * Basic smartphone skills * Sufficient knowledge of German (native language, C1 or C2) * Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer) * Consent to be informed of any additional findings Healthy controls: * Age: 50-80 years * 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 * Basic smartphone skills * Sufficient knowledge of German (native language, C1 or C2) * Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer) * Consent to be informed of any additional findings Exclusion Criteria: iRBD: * 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) Healthy controls: * 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) * clinically diagnosed iRBD
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What it tests

  • Increase of physical activity volume and intensity with the use of a motivational smartphone application
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Where

1 site
University Hospital of Bonn
Bonn, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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