Parkinson DiseaseALPHA-FITNCT07324330
Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
A study testing Increase of physical activity volume and intensity with the use of a motivational smartphone application in people with Parkinson Disease and Prodromal Stage, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases
- What is being tested?
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 4 Dec 2025to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily L Fitzgibbon, M.Sc. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Bonn
Bonn, North Rhine West-Falia, 53111
Michael B Sommerauer, Dr., +49 0228 287 - 19436, Michael.Sommerauer@ukbonn.de
About this study
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.
Read the detailed description
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:
- 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
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies
- Being tested
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
- Keywords
- intervention, movement, iRBD, prodromal parkinson's, non-pharmacologic, alpha-synucleinopathy, biomarker, cognitive decline, executive function, MRI, lifestyle, prevention, RCT, motor decline, smartphone, smartwatch, accelerometer, scalable, prodromal, PD
- Medical subject headings
- Parkinson Disease, Prodromal Symptoms, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase of physical activity volume and intensity with the use of a motivational smartphone applicationBehavioural
Also called Motivational movement intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| Doubling of baseline step count | Experimental | Large increase in step count and moderate to vigorous physical activity relative to baseline level (+100%). Receives: Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application |
| Small increase of baseline step count | Active comparator | Small increase in step count and moderate to vigorous physical activity relative to baseline level (+10%). Receives: Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (11)
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.
Measured: 12 months
Motor functions: Change Perdue-Pegboard-Test
Change in score. Higher scores indicates better manual dexterity and hand coordination.
Measured: 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).
Measured: 12 months
Change in body composition
Change in body composition measured through MRI sequences and bio-electric impedance analysis.
Measured: 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.
Measured: 12 months
Sleep behavior: Change in Polysomnography (PSG) read-outs
Change in PSG read-outs.
Measured: 12 months
Change in blood-based markers for metabolism.
Change found in biomarkers in plasma, serum and peripheral blood mononuclear cells (PBMCs).
Measured: 12 months
Change in blood-based markers for neurodegeneration.
Change found in biomarkers in plasma, serum and PBMCs
Measured: 12 months
Change in blood-based markers for inflammation.
Change found in biomarkers in plasma, serum and PBMCs
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start4 Dec 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Medical University Innsbruck, IJsfontein B.V., Netherlands, Synaptikon GmbH, Parkinson Stiftung
- Responsible party
- Principal investigator, Dr. Michael Sommerauer, University Hospital, Bonn
- Investigators
- Michael B Sommerauer, Dr., Principal investigator, University Hospital of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324330
- Sponsor's protocol ID
- 2025-289-BO
- Other IDs
- 01EA2501, 101095426
- Acronym
- ALPHA-FIT
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make relevant anonymised data available in a database.
Publications
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.
PubMed 22275317Kim 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.
PubMed 37922635Jia 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.
PubMed 31266451Jellinger 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.
PubMed 29510692Janssen 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.
PubMed 35970584Höglinger, 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.
PubMed 30646166Dorsey 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.
PubMed 30584159de 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.
PubMed 34724528Dauvilliers 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.
PubMed 30166532Cesari 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.
PubMed 34694408Bliss 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.
PubMed 32954902Berg 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.
PubMed 33879872Barone 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.
PubMed 19514014Aarsland 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.
PubMed 34210995
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
- ClinicalTrials.gov ID
- NCT07324330
- Acronym / sponsor ID
- ALPHA-FIT / 2025-289-BO
- Conditions
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies
- Keywords
- intervention, movement, iRBD, prodromal parkinson's, non-pharmacologic, alpha-synucleinopathy, biomarker, cognitive decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Medical University Innsbruck, IJsfontein B.V., Netherlands, Synaptikon GmbH, Parkinson Stiftung
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doubling of baseline step count | Experimental | Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone applicationLarge increase in step count and moderate to vigorous physical activity relative to baseline level (+100%). |
| Small increase of baseline step count | Active comparator | Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone applicationSmall increase in step count and moderate to vigorous physical activity relative to baseline level (+10%). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
- Relevant cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increase of physical activity volume and intensity with the use of a motivational smartphone applicationAlso: Motivational movement interventionA 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). | Behavioural | Doubling of baseline step count, Small increase of baseline step count |
Primary outcome
Cognitive Performance: Change in mild cognitive impairment (MCI) in PD Level II Criteria
Time frame: 12 months
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
11 secondary outcomes
Motor functions: Change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III
Time frame: 12 months
Motor functions: Change Perdue-Pegboard-Test
Time frame: 12 months
Motor functions: Change in digital testing outcomes
Time frame: 12 months
Change in body composition
Time frame: 12 months
Sleep behavior: Change in subjective sleep quality
Time frame: 12 months
Sleep behavior: Change in Polysomnography (PSG) read-outs
Time frame: 12 months
Change in blood-based markers for metabolism.
Time frame: 12 months
Change in blood-based markers for neurodegeneration.
Time frame: 12 months
Change in blood-based markers for inflammation.
Time frame: 12 months
Cognitive performance: Change in performance in digital app
Time frame: 12 months
Change in Quantitative MRI Measures of Brain Structure and Function
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 22275317Litvan 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.
- Background: PubMed 37922635Kim 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.
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- Individual participant dataSharing planned: Yes. We will make relevant anonymised data available in a database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily L Fitzgibbon, M.Sc. contact
Michael B Sommerauer, Dr. principal investigator
University Hospital of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase of physical activity volume and intensity with the use of a motivational smartphone application in people with Parkinson Disease and Prodromal Stage, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin M Rodemann (+49 0228 287 - 19436, Martin.Rodemann@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance: Change in mild cognitive impairment (MCI) in PD Level II Criteria (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07324330, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.