Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)

Study Overview
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Brief Summary
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Aging is often associated with pathological pathway such as in Mild Cognitive Impairment (MCI), and that pathway may be associated to a high risk of dementia. Tools for early identification of functional and cognitive decline and effectiveness of treatments in counteracting the loss of functionality to preserve MCI subjects autonomy, have been widely debated in recent years. In literature, the importance of combined cognitive and physical training is also recognized (Karssemeijer E, 2017). Moving from the above mentioned findings and considerations, the aim of GOAL project is to test a newly developed tele-rehabilitation platform to monitor and preserve functional and cognitive abilities in individuals affected by Mild Cognitive Impairment (MCI). Participants will be enrolled and randomly assigned to the tele-rehabilitation (GOAL group) or usual care program (control group). A dedicated application will be developed for the GOAL group. Thanks to the application, the participant will access different contents, such as serious games to train cognitive abilities (Anguera et al,2013) and physical training video lessons to endorse daily activity. Each participant of GOAL group will be provided with a tablet, with the application installed on it, and an internet connection (if needed).

Detailed Description
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30 patients will be allocated in the treatment arm (Telerehabilitation program, GOAL group) by randomization. Randomization will be applied with a ratio of 1:1. The Telerehabilitation program is conceived as a combined protocol to train both cognitive and physical domains. Participants will be requested to perform the cognitive training three times weekly and physical training two times weekly, on alternate days. The subject will access the Telerehabilitation contents by using a web application configured on a touchscreen notebook, that will be provided to each participant by the research institute. Physical exercises are going to be chosen according to adaptive physical activity model, and each session will be made up of eleven exercises, divided in three categories: warm-up, strengthening and stretching/relaxation. The participants will perform the exercises according to instructions received in a sequence of videos. Every session will last 30 minutes. Cognitive training will be based on BrainHQ exercises (BrainHQ, Posit Science,USA) which are characterized by adaptive control of the difficulty levels. The chosen exercises aim to train different cognitive domains including: attention, executive function, memory, processing speed, reasoning, and visuospatial memory. Each session will last 20 minutes, and will include four different types of exercise. While enrolled in the 8 weeks program, participants will also be requested to wear an actigraph. The actigraph will be placed on the non-dominant arm and will be used to monitor daily activity and sleep quality. At the end of the tele-rehabilitation program, participants will undergo a final assessment.

Official Title
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Home-rehabilitation Protocol in Elderly Subjects With Mild Cognitive Impairment (MCI) Based on Information and Communications Technology (ICT) and Serious Games for Cognitive and Physical Training. Games for Older Adults Active Life (GOAL)

Conditions
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Cognitive Dysfunction, Mild Cognitive Impairment, Vascular Cognitive Impairment

Intervention / Treatment
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* Other: Tele-rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age between 65 and 80 years old Agreement to participate, with signature of the informed-consent form Availability of a caregiver/study partner, who agrees to support the participant through the GOAL program. Participant and caregiver are not required to live together Mini Mental State Examination (MMSE) score >24 The participant should present a mild cognitive impairment (MCI) in absence of secondary causes of dementia (hypothyroidism untreated or treated with a therapy that has been revised in the previous 6 months, vitamin B12 or folate deficiency), assessed through a blood test. In case of MCI due to Alzheimer Disease (AD), additional inclusion criteria are: Hachinski Ischemic Score ≤4 Absence of secondary causes of dementia confirmed by a neuroimaging examination (TC scan or encephalic MRI), Fazekas score <2 Biomarker of neuronal damage (PET with 18f-fluorodeoxyglucose, MRI with hippocampal volumetric assessment or levels of t-tau and p-tau in the cerebrospinal fluid) or biomarkers of Aβ deposition (Amyloid-PET or levels of A> 42 in the cerebrospinal fluid) consistent with MCI due to AD In case of MCI due to Vascular Cognitive Impairment, additional inclusion criteria are: Hachinski Ischemic score > 4 Fazekas score >=2 Presence of at least one of the following conditions, as assessed by TC scan or encephalic MRI Multiple lesions in the white matter consistent with cerebral small vessel disease Lacunar status Multi-infarct encephalopathy with ischemic multiple lesions in the cortical region, in the basal ganglia and white matter Exclusion Criteria: Unreliable communication (eg, foreign language or aphasia) Severe visual or auditory deficit, not reversible, to the extent that it compromises the interaction with the operator and the usage of ICT instrumentation. Presence of neurological and/or psychiatric disorders (Hamilton scale >12) that might interfere with cognitive status Left-handed individuals Level of education <3 years History of substance abuse (nicotine excluded) Having relapsing systemic disease and presence of major head trauma Frank dementia MMSE <24

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-rehabilitation<br>Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises | Other: Tele-rehabilitation<br>* Each subject undergoes a combined rehabilitation protocol, which will be administered on a daily basis, designed to alternate physical exercises and cognitive training. Each daily session lasts between 30 and 45 minutes. The complete protocol lasts 8 weeks.<br>|
| No Intervention: Control group<br>Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the cognitive ability measured at the end of the treatment (time point 2 months) and at the screening time point | Changes in cognitive ability will be assessed by Montreal Cognitive Assessment (MoCA) Test (Conti et al., 2014) | At the screening time point and after 2 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance or improvement of the physical activity | Physical activity performed during the trial will be evaluated through the output of the actigraph device and physical performance using the Short Physical Performance Battery | At the screening time point and after 2 months of treatment | 
| Copy and Recall of Rey's Figure | Copy and Recall of Rey's Figure ( Caffarra et al., 2002) | At the screening time point and after 2 months of treatment | 
| Verbal fluency task | Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996) | At the screening time point and after 2 months of treatment | 
| Stroop Test | Stroop Test (short version; Caffarra et al., 2002) | At the screening time point and after 2 months of treatment | 
| Serious Game test | Serious Game test (Zucchella et al, 2014) | At the screening time point and after 2 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telerehabilitation [E02.831.891], Cognitive Aging [G07.345.124.260], Exercise Therapy [E02.760.169.063.500.387]