Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
NCT ID: NCT07324330
Last Updated: 2026-01-16
Study Results
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Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-12-04
2029-12-01
Brief Summary
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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.
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Detailed Description
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Isolated REM sleep behavior disorder (iRBD) is considered an early sign of α-synucleinopathy and can be reliably diagnosed using video polysomnography. Over 90% of individuals with iRBD develop either PD or DLB within 20 years of diagnosis, with an approximately equal distribution between the two entities. It is noteworthy that executive functions can often already be impaired in iRBD, which is associated with an increased risk of early conversion to PD or DLB. Thus, iRBD represents a phase of early neurodegeneration in which there is a high risk of cognitive decline. For this reason, individuals with iRBD are a particularly suitable target group for investigating the effects of lifestyle modifications that could slow the progression of the disease at an early stage.
Increasing physical activity could offer a promising way to slow the progression of neurodegenerative processes in the early stages of α-synucleinopathies. Since motor impairments are a central feature of PD and DLB, many affected individuals-even in the early stages of the disease-do not achieve the recommended level of physical activity. Studies on increasing physical activity have shown that physical training has positive effects on cerebrovascular function and cognitive performance, both in healthy aging and in various neurodegenerative diseases. For α-synucleinopathies in particular, there is evidence from animal models, observational studies, and clinical trials with up to six months of follow-up that physical activity may have disease-modifying effects. A recent meta-analysis in PD found that various interventions to increase physical activity have moderate effects on global cognition and even strong effects on executive functions. Therefore, promoting a more active lifestyle could be a promising strategy to positively influence the early course of α-synucleinopathies. Motivational mobile apps offer a novel way to increase physical activity, as they can be used completely independently, allowing for a high degree of scalability of the intervention.
Derivation of research questions
The following key questions will be addressed in the research project:
* Can the progression of motor and cognitive changes in individuals with iRBD be influenced by increasing physical activity?
* Does this intervention also affect biological and imaging markers of pathological brain aging?
* Does this intervention also have an effect on healthy older people?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Doubling of baseline step count
Large increase in step count and moderate to vigorous physical activity relative to baseline level (+100%).
Increase of physical activity volume and intensity with the use of a motivational smartphone application
A 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).
Small increase of baseline step count
Small increase in step count and moderate to vigorous physical activity relative to baseline level (+10%).
Increase of physical activity volume and intensity with the use of a motivational smartphone application
A 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).
Interventions
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Increase of physical activity volume and intensity with the use of a motivational smartphone application
A 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Medical University Innsbruck
OTHER
IJsfontein B.V., Netherlands
UNKNOWN
Synaptikon GmbH
UNKNOWN
Parkinson Stiftung
UNKNOWN
University Hospital, Bonn
OTHER
Responsible Party
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Dr. Michael Sommerauer
Senior Consultant Physician, Head of the Sleep Laboratory
Principal Investigators
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Michael B Sommerauer, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Bonn
Locations
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University Hospital of Bonn
Bonn, North Rhine West-Falia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Jia RX, Liang JH, Xu Y, Wang YQ. Effects of physical activity and exercise on the cognitive function of patients with Alzheimer disease: a meta-analysis. BMC Geriatr. 2019 Jul 2;19(1):181. doi: 10.1186/s12877-019-1175-2.
Jellinger KA, Korczyn AD. Are dementia with Lewy bodies and Parkinson's disease dementia the same disease? BMC Med. 2018 Mar 6;16(1):34. doi: 10.1186/s12916-018-1016-8.
Janssen Daalen JM, Schootemeijer S, Richard E, Darweesh SKL, Bloem BR. Lifestyle Interventions for the Prevention of Parkinson Disease: A Recipe for Action. Neurology. 2022 Aug 16;99(7 Suppl 1):42-51. doi: 10.1212/WNL.0000000000200787.
Höglinger, G. U. et al. Towards a Biological Definition of Parkinson's Disease. Preprint at https://doi.org/10.20944/preprints202304.0108.v1 (2023).
Fang X, Han D, Cheng Q, Zhang P, Zhao C, Min J, Wang F. Association of Levels of Physical Activity With Risk of Parkinson Disease: A Systematic Review and Meta-analysis. JAMA Netw Open. 2018 Sep 7;1(5):e182421. doi: 10.1001/jamanetworkopen.2018.2421.
Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.
Kim R, Lee TL, Lee H, Ko DK, Lee JH, Shin H, Lim D, Jun JS, Byun K, Park K, Jeon B, Kang N. Effects of physical exercise interventions on cognitive function in Parkinson's disease: An updated systematic review and meta-analysis of randomized controlled trials. Parkinsonism Relat Disord. 2023 Dec;117:105908. doi: 10.1016/j.parkreldis.2023.105908. Epub 2023 Oct 26.
de Vries NM, Darweesh SKL, Bloem BR. Citius, Fortius, Altius-Understanding Which Components Drive Exercise Benefits in Parkinson Disease. JAMA Neurol. 2021 Dec 1;78(12):1443-1445. doi: 10.1001/jamaneurol.2021.3744. No abstract available.
Dauvilliers Y, Schenck CH, Postuma RB, Iranzo A, Luppi PH, Plazzi G, Montplaisir J, Boeve B. REM sleep behaviour disorder. Nat Rev Dis Primers. 2018 Aug 30;4(1):19. doi: 10.1038/s41572-018-0016-5.
Cesari M, Heidbreder A, St Louis EK, Sixel-Doring F, Bliwise DL, Baldelli L, Bes F, Fantini ML, Iranzo A, Knudsen-Heier S, Mayer G, McCarter S, Nepozitek J, Pavlova M, Provini F, Santamaria J, Sunwoo JS, Videnovic A, Hogl B, Jennum P, Christensen JAE, Stefani A. Video-polysomnography procedures for diagnosis of rapid eye movement sleep behavior disorder (RBD) and the identification of its prodromal stages: guidelines from the International RBD Study Group. Sleep. 2022 Mar 14;45(3):zsab257. doi: 10.1093/sleep/zsab257.
Bliss ES, Wong RH, Howe PR, Mills DE. Benefits of exercise training on cerebrovascular and cognitive function in ageing. J Cereb Blood Flow Metab. 2021 Mar;41(3):447-470. doi: 10.1177/0271678X20957807. Epub 2020 Sep 20.
Berg D, Borghammer P, Fereshtehnejad SM, Heinzel S, Horsager J, Schaeffer E, Postuma RB. Prodromal Parkinson disease subtypes - key to understanding heterogeneity. Nat Rev Neurol. 2021 Jun;17(6):349-361. doi: 10.1038/s41582-021-00486-9. Epub 2021 Apr 20.
Barone P, Antonini A, Colosimo C, Marconi R, Morgante L, Avarello TP, Bottacchi E, Cannas A, Ceravolo G, Ceravolo R, Cicarelli G, Gaglio RM, Giglia RM, Iemolo F, Manfredi M, Meco G, Nicoletti A, Pederzoli M, Petrone A, Pisani A, Pontieri FE, Quatrale R, Ramat S, Scala R, Volpe G, Zappulla S, Bentivoglio AR, Stocchi F, Trianni G, Dotto PD; PRIAMO study group. The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease. Mov Disord. 2009 Aug 15;24(11):1641-9. doi: 10.1002/mds.22643.
Aarsland D, Batzu L, Halliday GM, Geurtsen GJ, Ballard C, Ray Chaudhuri K, Weintraub D. Parkinson disease-associated cognitive impairment. Nat Rev Dis Primers. 2021 Jul 1;7(1):47. doi: 10.1038/s41572-021-00280-3.
Other Identifiers
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01EA2501
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
101095426
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2025-289-BO
Identifier Type: -
Identifier Source: org_study_id
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