The study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the subsequent LLM Care (NCT02313935) projects in patients with Parkinson's Disease (PD). The study aims to examine the viability and any potential benefits of cognitive and physical training, as offered via the ICT-based (non-pharmacological) intervention of LLM Care, on people with PD. It is worth investigating whether this intervention can offer a better quality of life in patients with PD and counterbalance the often associated with the PD disease neurodegeneration. To evaluate any physical, cognitive, behavioral, and neuroplastic changes and measure the influence (affective status of participant) of the training on the pathological population, the study utilizes somatometric and neuropsychological assessments and neuroscientific (electroencephalographic, EEG-related) indices, as well as affective computing systems.
Parkinson's Disease (PD) is a highly prevalent chronic neurodegenerative disease of the central nervous system, with both motor and non-motor symptoms, having a high impact on the quality of life of the patients. There is still no cure available for individuals with PD but only pharmaceutical treatments that manage the symptoms, thus non-pharmaceutical treatments such as physical and cognitive training are of great importance. This study aims to evaluate the benefits of the LLM Care (NCT02313935) Integrated Healthcare System (https://www.llmcare.gr/en/home/), which is a successful example of commercializing the LLM (NCT02267499) research program (http://www.longlastingmemories.eu/), in patients with PD. The LLM Care (non-pharmaceutical) intervention is an integrated training system that targets nondemented and demented aging population and adopts an approach of cognitive and physical training to improve the quality of life and prolong the functionality of the elders. The physical training (PT) component of the LLM, WebFitForAll, was developed by the research team of the Medical Physics Laboratory, Department of Medicine, Aristotle University of Thessaloniki. WebFitForAll is an effective physical platform that strengthens the body and enhances aerobic capacity, flexibility, and balance. The cognitive training (CT) component of the LLM is a Greek adaptation of the BrainHQ online interactive environment, and comprises six categories with 29 brain exercises with hundred levels of difficulty. The exercises focus on attention, memory, brain speed, people skills, navigation, and intelligence. The target population is PD patients which were classified according to their cognitive state as PD-cognitively normal (PD-CN) and PD-mild cognitive impairment (PD-MCI). Both PD-CN and PD-MCI followed similar training schemes of the intervention, two times per week for one hour for a total of 10 weeks (aiming at 20 sessions/individual). Specifically, the patients were categorized as follows: (i) LLM training group, where participants attended a training protocol consisting of pseudo-randomized physical and cognitive exercises (30 minutes of cognitive and 30 minutes of physical training), (ii) physical training group, whereas participants underwent only physical training (one hour of physical training), and (iii) cognitive training group, in which participants performed cognitive tasks (one hour of cognitive training). The main goal of this study is to quantify the effects of implementing the LLM Care intervention on patients with PD, determine any benefits in physical status, cognition, behavior, and brain function, and eventually assess if adopting a cognitively and physically stimulating lifestyle can offer a better quality of life in this pathological group. All of the patients were evaluated at baseline (pre) and exit (post) via EEG measures and a battery of routinely used clinical and neuropsychological tests. Additionally, the training platform utilizes affective computing systems to evaluate the affective status of all participants throughout the training and to establish a pleasant learning environment for all participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
23
PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)
CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)
Laboratory of Medical Physics, AUTH
Thessaloniki, Greece
Change in current density strength of the cortical activity as measured via EEG.
Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings before compared to after the training.
Time frame: 2 months
Changes in the cortical directed connectivity as measured via EEG
Changes in the cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Phase Transfer Entropy (PTE) estimated from the cortical activity, as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings, before compared to after the training.
Time frame: 2 months
Changes in the graph theory indexes as measured via EEG
Changes in the global and local graph theoretical indexes of the brain networks caused via the training. Change is defined as statistically significance in the t-test comparison of the graph theory indexes, before compared to after the training.
Time frame: 2 months
Physical capacity (mobility)
Change in walking speed as measured via the 10 Meter Walk test (Walking Speed m/s; Household Ambulator: \<0.40 m/s; Limited Community Ambulator: 0.40 to \<0.80 m/s; Community Ambulator: ≥0.80 m/s)
Time frame: 2 months
Change in physical capacity (gait and balance, fall risk)
Change in gait and balance, and fall risk as measured via the Tinetti POMA (scale: 0-28; gait is scored over 12; balance is scored over 16; perfect: 28; the lower the score on the Tinetti test, the higher the risk of falling; High risk of fall: ≤ 18; Moderate risk of fall: 19-23; Low risk of fall≥ 24)
Time frame: 2 months
Body Weight index
BMI
Time frame: 2 months
Fitness
Change in Fitness. Change in aerobic fitness, strength, and flexibility as measured via the Fullerton Senior Fitness Test (SFT)
Time frame: 2 months
Physical capacity (balance & mobility)
Community Balance \& Mobility: balance and mobility, scale: 0-96 perfect:96
Time frame: 2 months
Physical capacity (Functional mobility)
Berg Balance Scale: functional mobility, scale: 0-56 perfect:56
Time frame: 2 months
Quality of life index
PDQ-8: activities of daily living, attention and working memory, communication, depression, quality of life, and social relationships in persons with Parkinson's Disease, scale: 0-100 (0: good health, 100: poor health)
Time frame: 2 months
Depression
GDS: depressive symptoms, scale: 0-15 (normal: 0-5; mild depression: 5-8; moderate depression: 9-11; severe depression: 12-15)
Time frame: 2 months
Physical capacity (general)
Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12, perfect 12)
Time frame: 2 months
Cognitive capacity (functional)
MMSE: orientation, attention, memory, language and visual-spatial skills, scale: 0-30 perfect:30
Time frame: 2 months
Cognitive capacity (Visuospatial attention)
Change in visuospatial attention as measured via Trail Making Test (TMT, duration of completion)
Time frame: 2 months
Cognitive capacity
Change in cognitive function as measured via the Montreal Cognitive Assessment (MOCA, scale: 0-30; perfect: 30; normal: ≥26)
Time frame: 2 months
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