Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI (HomeFitPD)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); PARKINSON DISEASE (Disorder)
• Intervention / Treatment: Behavioral: Dual-task Cognitive Motor Training; Behavioral: Cognitive Motor Training

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inga Liepelt-Scarfone, Prof. Dr.; Phone Number: +497071298ß424; Email: Inga.Liepelt@uni-tuebingen.de
• Study Contact Backup: Name: Merle Bode, MSc; Phone Number: +4970712980424; Email: Merle.Bode@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • University Hospital Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: Cognitive Motor Training; Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes.	Behavioral: Cognitive Motor Training; Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Parkinson Stiftung

Publications and helpful links

General Publications

• [13] K.P. Pereira-Pedro, I.M. de Oliveira, I. Mollinedo-Cardalda, J.M. Cancela-Carral, 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 19(13) (2022).
• [12] P.L. Wong, S.J. Cheng, Y.R. Yang, R.Y. Wang, Effects of Dual Task Training on Dual Task Gait Performance and Cognitive Function in Individuals With Parkinson Disease: A Meta-analysis and Meta-regression, Archives of physical medicine and rehabilitation 104(6) (2023) 950-964.
• [11] H. Johansson, A.K. Folkerts, I. Hammarstrom, E. Kalbe, B. Leavy, Effects of motor-cognitive training on dual-task performance in people with Parkinson's disease: a systematic review and meta-analysis, J Neurol 270(6) (2023) 2890-2907.
• [10] M. Schmitter-Edgecombe, C. McAlister, D. Greeley, 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 28(8) (2022) 798-809.
• [9] T.E. Raffegeau, L.M. Krehbiel, N. Kang, F.J. Thijs, L.J.P. Altmann, J.H. Cauraugh, C.J. Hass, A meta-analysis: Parkinson's disease and dual-task walking, Parkinsonism Relat Disord 62 (2019) 28-35.
• 8] S. Becker, M. Bode, K. Brockmann, T. Gasser, K. Michaelis, S. Solbrig, H.C. Nuerk, C. Schulte, W. Maetzler, M. Zimmermann, D. Berg, I. Liepelt-Scarfone, Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study, Neurology (2022).
• [7] S.C.F. van de Weijer, A.A. Duits, B.R. Bloem, N.M. de Vries, R.P.C. Kessels, S. Kohler, G. Tissingh, M.L. Kuijf, Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study, Eur Neurol 83(4) (2020) 426-432.
• [6] B.J. Lawrence, N. Gasson, A.R. Johnson, L. Booth, A.M. Loftus, Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial, Parkinsons Dis 2018 (2018) 4318475.
• [5] E. Fiorenzato, S. Zabberoni, M.S. De Simone, A. Costa, G. Tieri, S. Taglieri, A. Peppe, G.A. Carlesimo, C. Caltagirone, A. Antonini, G. Cona, Effects of virtual reality cognitive training on executive function and prospective memory in Parkinson's disease and healthy aging, J Neurol Sci 473 (2025) 123507.
• [4] I. Leroi, S. Vatter, L.A. Carter, S.J. Smith, V. Orgeta, E. Poliakoff, M.A. Silverdale, J. Raw, D.J. Ahearn, C. Taylor, J. Rodda, T. Abdel-Ghany, S.A. McCormick, Parkinson's-adapted cognitive stimulation therapy: a pilot randomized controlled clinical trial, Ther Adv Neurol Disord 12 (2019) 1756286419852217.
• [3] S. Tagliente, B. Minafra, S. Aresta, P. Santacesaria, A. Buccoliero, C. Palmirotta, G. Lagravinese, D. Mongelli, C. Gelao, L. Macchitella, S. Pazzi, D. Scrutinio, P. Baiardi, P. Battista, Effectiveness of a home-based computerized cognitive training in Parkinson's disease: a pilot randomized cross-over study, Frontiers in psychology 15 (2024) 1531688.
• [2] R. van den Bergh, B.R. Bloem, M.J. Meinders, L.J.W. Evers, The state of telemedicine for persons with Parkinson's disease, Current opinion in neurology 34(4) (2021) 589-597.
• [1] D. Peacock, P. Baumeister, A. Monaghan, J. Siever, J. Yoneda, D. Wile, Perception of Healthcare Access and Utility of Telehealth Among Parkinson's Disease Patients, Can J Neurol Sci 47(5) (2020) 700-704.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson's disease; Dual task training; Activities of daily living function; Hometraining
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Cognitive Dysfunction; Parkinson Disease
• Other Study ID Numbers: 2025-0681-BO (Other Identifier: Ethics Committee of the Medical Faculty)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing with other researchers requiere the permission of our ethic committee and a data transfer agreement
• IPD Sharing Time Frame: IPD will be available upon request
• IPD Sharing Access Criteria: Data can be requested by the primary contact persons of this study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No