An interventional study of Increase of physical activity volume and intensity with the use of a motivational smartphone application in Parkinson Disease, Prodromal Stage and Neurodegenerative Diseases, sponsored by University Hospital, Bonn. Recruiting at 1 site in Germany. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by University Hospital, Bonn · Not applicable, Interventional, and Prevention
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.
α-Synucleinopathies are the second most common group of neurodegenerative diseases after Alzheimer's disease (AD). Their prevalence is expected to increase significantly, with more than 12 million people worldwide likely to be affected by 2040. Clinical manifestations include Parkinson's disease (PD) and dementia with Lewy bodies (DLB). These diseases are characterized by neuronal inclusions of α-synuclein aggregates and Lewy bodies, which lead to premature aging of the brain. In addition to motor impairments, cognitive decline is a central element of non-motor symptoms, which not only occurs in DLB but also affects up to 80% of people with PD. Cognitive deficits can often occur in the early stages of the disease and significantly impair social functioning and quality of life. Despite their high prevalence, there are currently only a few therapeutic approaches for treating cognitive impairments in α-synucleinopathies. Therefore, easily accessible, early preventive interventions are crucial to counteract cognitive decline.
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:
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 130 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 28 are open to participants now.
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iRBD:
Healthy controls:
Exclusion Criteria:
iRBD:
Healthy controls:
Large increase in step count and moderate to vigorous physical activity relative to baseline level (+100%).
Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application
Small increase in step count and moderate to vigorous physical activity relative to baseline level (+10%).
Behavioral: 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).
Also known as: Motivational movement intervention
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
Time frame: 12 months
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.
Time frame: 12 months
Motor functions: Change Perdue-Pegboard-Test
Change in score. Higher scores indicates better manual dexterity and hand coordination.
Time frame: 12 months
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).
Time frame: 12 months
Change in body composition
Change in body composition measured through MRI sequences and bio-electric impedance analysis.
Time frame: 12 months
Sleep behavior: Change in subjective sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI), with scores between 0 and 21, higher scores indicate worse sleep.
Time frame: 12 months
Sleep behavior: Change in Polysomnography (PSG) read-outs
Change in PSG read-outs.
Time frame: 12 months
Change in blood-based markers for metabolism.
Change found in biomarkers in plasma, serum and peripheral blood mononuclear cells (PBMCs).
Time frame: 12 months
Change in blood-based markers for neurodegeneration.
Change found in biomarkers in plasma, serum and PBMCs
Time frame: 12 months
Change in blood-based markers for inflammation.
Change found in biomarkers in plasma, serum and PBMCs
Time frame: 12 months
Cognitive performance: Change in performance in digital app
Change in performance in the https://www.neuronation.com/ app. Will be measured in 2-week intervals.
Time frame: 12 months
Change in Quantitative MRI Measures of Brain Structure and Function
Change from baseline to 12 months in MRI-derived quantitative measures of brain structure and function, including resting-state functional magnatic resonance imaging (fMRI), T1-weighted structural measures, fluid-attenuated inversion recovery (FLAIR) based measures, quantitative susceptibility mapping (QSM) metrics, and neuromelanin-sensitive MRI signal measures.
Time frame: 12 months
Plan to share: Yes — We will make relevant anonymised data available in a database.
Supporting information: Study protocol
Time frame: We will make relevant anonymised data available in a database after publication of the main results of our trial.
Access criteria: Researchers who are interested in re-use of the data are asked to contact the central contact person for permission.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 35 months is above that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
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