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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-0681-BO | Other Identifier | Ethics Committee of the Medical Faculty |
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| Name | Class |
|---|---|
| Parkinson Stiftung | UNKNOWN |
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Telerehabilitation is a promising tool for treating and preventing further disease progression in Parkinson's disease (PD) [1, 2]. First studies in people with PD (PwPD) verified the feasibility of home-based digital cognitive training [3-7]. Progression in cognitive impairment and the onset and worsening of problems with complex everyday tasks are hallmarks of the prodromal phase of Parkinson's disease dementia (PDD). Consequently, the risk of PDD conversion is dramatically increased for PwPD with both mild cognitive impairment (PD-MCI) and complex activities of daily living (ADL) problems related to cognitive impairment [8]. Therefore, this group may be a promising target group for interventions, as they are at risk for serious and rapidly progressive cognitive deterioration.
PwPD with PD-MCI show deficits in motor-cognition [9] and attentional-control, both of which affect ADL [10]. Dual-task cognitive trainings (DCT) shows great potential to lower down the disease process [11, 12], but so far no home-based DCT with the primary endpoint of complex ADL and cognition has been conducted in PwPD. We adapted an on-site DCT to improve both physical and cognitive function in PwPD [13]. The training will be conducted as a telerehabilitation training in PwPD with PD-MCI and cognitive ADL impairment, identified with the Functional Activities Questionnaire (FAQ). Of PwPD with PD-MCI who have more cognitive rather than motor associated ADL dysfunction (reflected by a value of the FAQ quotient > 1.008), nearly 50% develop dementia (PDD) within three years [8].
In our single-center randomized, controlled non-pharmacological intervention, 42 PwPD with PD-MCI and FAQ quotient >1.008 will be assessed with pre-(T0) and post(T1), 6-months (T2) and 12-month follow-up (T3) testing. After 1:1 randomization to either the experimental DCT or the control motor training (CMT), both groups will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes. While cycling, the DCT group will additionally perform digital cognitive training on a tablet, covering attention, working memory and executive function. The cognitive training will automatically adapt to performance levels and is remotely accessible. The training is aimed to enhance cognition as well as ADL and to prevent its further decline, with an emphasis on maintaining ADLs in the prodromal stage of Parkinson's disease dementia (PDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-task Cognitive-Motor Training | Experimental | Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30. While cycling, the DCT group will additionally perform digital cognitive training on a tablet, covering attention, working memory and executive function. The cognitive training will automatically adapt to performance levels and is remotely accessible. |
|
| Cognitive Motor Training | Active Comparator | Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-task Cognitive Motor Training | Behavioral | Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30. While cycling, the DCT group will additionally perform digital cognitive training on a tablet, covering attention, working memory and executive function. The cognitive training will automatically adapt to performance levels and is remotely accessible. |
| Measure | Description | Time Frame |
|---|---|---|
| Informant rated cognition score of the Functional Activity Questionnaire (FAQ) | Values ranged from 0 to 12 points, with higher values indicating more severe cognitive ADL impairment | Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3) |
| Auditory Stroop Test | Auditory word were presented in high and low pitch, reaction time for classifying the high and low pitch not the word spoken is registered over 20 trials | Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inga Liepelt-Scarfone, Prof. Dr. | Contact | +497071298ß424 | Inga.Liepelt@uni-tuebingen.de | |
| Merle Bode, MSc | Contact | +4970712980424 | Merle.Bode@med.uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35805505 | Background | Pereira-Pedro KP, de Oliveira IM, Mollinedo-Cardalda I, Cancela-Carral JM. Effects of Cycling Dual-Task on Cognitive and Physical Function in Parkinson's Disease: A Randomized Double-Blind Pilot Study. Int J Environ Res Public Health. 2022 Jun 26;19(13):7847. doi: 10.3390/ijerph19137847. | |
| 36574531 | Background |
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Data sharing with other researchers requiere the permission of our ethic committee and a data transfer agreement
IPD will be available upon request
Data can be requested by the primary contact persons of this study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2026 | Feb 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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fter 1:1 randomization to either the experimental dual task cognitive-motor training (DCT) or the control motor training (CMT).
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|
| Cognitive Motor Training | Behavioral | Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30. |
|
| Wong PL, Cheng SJ, Yang YR, Wang RY. Effects of Dual Task Training on Dual Task Gait Performance and Cognitive Function in Individuals With Parkinson Disease: A Meta-analysis and Meta-regression. Arch Phys Med Rehabil. 2023 Jun;104(6):950-964. doi: 10.1016/j.apmr.2022.11.001. Epub 2022 Nov 28. |
| 36820916 | Background | Johansson H, Folkerts AK, Hammarstrom I, Kalbe E, Leavy B. Effects of motor-cognitive training on dual-task performance in people with Parkinson's disease: a systematic review and meta-analysis. J Neurol. 2023 Jun;270(6):2890-2907. doi: 10.1007/s00415-023-11610-8. Epub 2023 Feb 23. |
| 34486508 | Background | Schmitter-Edgecombe M, McAlister C, Greeley D. A Comparison of Functional Abilities in Individuals with Mild Cognitive Impairment and Parkinson's Disease with Mild Cognitive Impairment Using Multiple Assessment Methods. J Int Neuropsychol Soc. 2022 Sep;28(8):798-809. doi: 10.1017/S1355617721001077. Epub 2021 Sep 6. |
| 30594454 | Background | Raffegeau TE, Krehbiel LM, Kang N, Thijs FJ, Altmann LJP, Cauraugh JH, Hass CJ. A meta-analysis: Parkinson's disease and dual-task walking. Parkinsonism Relat Disord. 2019 May;62:28-35. doi: 10.1016/j.parkreldis.2018.12.012. Epub 2018 Dec 12. |
| 36240089 | Background | Becker S, Bode M, Brockmann K, Gasser T, Michaelis K, Solbrig S, Nuerk HC, Schulte C, Maetzler W, Zimmermann M, Berg D, Liepelt-Scarfone I. Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study. Neurology. 2022 Dec 5;99(23):e2548-e2560. doi: 10.1212/WNL.0000000000201201. |
| 32756067 | Background | van de Weijer SCF, Duits AA, Bloem BR, de Vries NM, Kessels RPC, Kohler S, Tissingh G, Kuijf ML. Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study. Eur Neurol. 2020;83(4):426-432. doi: 10.1159/000509685. Epub 2020 Aug 5. |
| 29780572 | Background | Lawrence BJ, Gasson N, Johnson AR, Booth L, Loftus AM. Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial. Parkinsons Dis. 2018 Mar 26;2018:4318475. doi: 10.1155/2018/4318475. eCollection 2018. |
| 40250092 | Background | Fiorenzato E, Zabberoni S, De Simone MS, Costa A, Tieri G, Taglieri S, Peppe A, Carlesimo GA, Caltagirone C, Antonini A, Cona G. Effects of virtual reality cognitive training on executive function and prospective memory in Parkinson's disease and healthy aging. J Neurol Sci. 2025 Jun 15;473:123507. doi: 10.1016/j.jns.2025.123507. Epub 2025 Apr 14. |
| 31320931 | Background | Leroi I, Vatter S, Carter LA, Smith SJ, Orgeta V, Poliakoff E, Silverdale MA, Raw J, Ahearn DJ, Taylor C, Rodda J, Abdel-Ghany T, McCormick SA. Parkinson's-adapted cognitive stimulation therapy: a pilot randomized controlled clinical trial. Ther Adv Neurol Disord. 2019 Jul 4;12:1756286419852217. doi: 10.1177/1756286419852217. eCollection 2019. |
| 39850970 | Background | Tagliente S, Minafra B, Aresta S, Santacesaria P, Buccoliero A, Palmirotta C, Lagravinese G, Mongelli D, Gelao C, Macchitella L, Pazzi S, Scrutinio D, Baiardi P, Battista P. Effectiveness of a home-based computerized cognitive training in Parkinson's disease: a pilot randomized cross-over study. Front Psychol. 2025 Jan 9;15:1531688. doi: 10.3389/fpsyg.2024.1531688. eCollection 2024. |
| 33990100 | Background | van den Bergh R, Bloem BR, Meinders MJ, Evers LJW. The state of telemedicine for persons with Parkinson's disease. Curr Opin Neurol. 2021 Aug 1;34(4):589-597. doi: 10.1097/WCO.0000000000000953. |
| 32450924 | Background | Peacock D, Baumeister P, Monaghan A, Siever J, Yoneda J, Wile D. Perception of Healthcare Access and Utility of Telehealth Among Parkinson's Disease Patients. Can J Neurol Sci. 2020 Sep;47(5):700-704. doi: 10.1017/cjn.2020.99. Epub 2020 May 26. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |