Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder

Study Overview
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Brief Summary
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This study evaluates the feasibility of the intervention and the study design.

Detailed Description
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This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

Official Title
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Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder

Conditions
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Exergame, Major Neurocognitive Disorder, Long-term Care Facility, Nursing Home

Intervention / Treatment
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* Device: Motor-cognitive training device
* Other: Active control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60+ years Living in residency de Wingerd in Leuven (at least two weeks here) Being able to straight for minimal 10 minutes without aids Visual acuity with correction sufficient to see on a TV screen diagnosed with major neurocognitive disorder Exclusion Criteria: Mobility impairments that don't allow to play the exergame Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension) Orthopaedic or neurological diseases that prevent exergame training Rapidly progressive or terminal illness

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Exergame intervention | Device: Motor-cognitive training device<br>* Motor-cognitive training device<br>* Other names: Vitaal exergame;|
| Sham Comparator: Control<br>Active control condition | Other: Active control condition<br>* Physical activity program<br>* Other names: Physical therapy program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety | 2 years | 
| Motor functions | Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery 1 - Minute Sit to Stand Test | 2 years | 
| Cognitive functions | Montréal Cognitive Assessment Mini-Mental State Examination | 2 years | 
| Mental health | Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life | 2 years |