Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI

Официальное название

Efficacy of Dual-task Telerehabilitation to Prevent Worsening in Activities of Daily Living in People With Parkinson's Disease at High Risk for Dementia: A Proof-of-concept Study

Обзор

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).

Вмешательства

• Поведенческое Dual-task Cognitive Motor Training
  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.
• Поведенческое Cognitive Motor Training
  Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30.

Первичные конечные точки

• Informant rated cognition score of the Functional Activity Questionnaire (FAQ) [Срок оценки: Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3)]
• Auditory Stroop Test [Срок оценки: Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3)]

Критерии участия

Критерии включения

• PD diagnosis confirmed by a neurologist
• PD diagnosis at least for one year
• Age between 51-80 years
• German as their mother tongue
• Diagnosis of PD-MCI according to the Level II criteria of the Movement Disorder Society
• Cognitive ADL impairment as defined by the FAQ quotient
• An informant who has given consent to provide information about the participant's activities of daily living (ADLs) and who lives in the participant's home.
• Access to a WIFI Network at home
• Unimpaired or corrected vision and hearing
• Appropriate text comprehension and reading ability
• Ability to communicate well with the investigator, to understand and comply with the requirements of the study
• Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care

Критерии исключения

• Diagnosis of PDD
• Intake of anti-dementia drugs
• Deep brain stimulation
• History of brain disease other than PD (e.g. head trauma, stroke, encephalitis) also including muscular diseases (e.g. myestenia gravis or myopathy)
• Pre-existing condition that limits limb movement (e.g. muscular injuries, knee and hip disorders
• severe cardiovascular diseases with heart failure
• severe respiratory diseases (e.g. asthma and lung disease)
• severe other accompanying illnesses with impairment of lung function
• renal insufficiency
• acute stage of infectious disease
• acute stage of cancer
• other disease with pronounced physical weakness
• History of brain disease other than PD, e.g., head trauma, stroke, encephalitis
• Alcohol, medication, or drug dependency or abuse (except for nicotine)
• Signs of severe depression indicated by either the 15 item version Geriatric Depression Scale (≥ 5 points)
• Acute psychosis
• Any disability or issues that may prevent the subject from completing the informed consent form or other study requirements
• Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study
• Participation in any clinical investigation of a new compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Германия · 1 центр

• University hospital Tübingen — Tübingen

Публикации

• 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. PMID 35805505
• 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. PMID 36574531
• 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. PMID 36820916
• 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. PMID 34486508
• 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. PMID 30594454
• 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. PMID 36240089
• 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. PMID 32756067
• 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. PMID 29780572

Идентификаторы

NCT: NCT07411365 · 2025-0681-BO · 2025-0681-BO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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