About this trial
This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders (MNCD) living in long-term care facilities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neurocognitive disorder based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to the criteria of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)
Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30
Disqualifiers
MMSE <5
Unstable cardiovascular condition or other medical condition that does not allow for safe participation according to the recommendations of the American College of Sports Medicine
Planned transfer to another facility within the next 3 months
Acute behavioural problems
Trial design
Parallel
Treatments tested in this trial
Exergaming on Dividat Senso
Other interventionThe active dance video game is played with the Dividat Senso (Dividat \| Senso: cognitive-motor training). It consists of a dance disc with four arrows (up, down, left, right), and the game is played on a large screen (which is connected to the PC). The screen indicates which arrow the person should step on, thus controlling the game through body movements. The games give the person feedback in the form of auditory, visual, and somatosensory stimuli.
Usual Care
Other interventionStandardised care with meal service, individual activities (e.g. hiking group, walking group, exercise group, handicrafts, gardening group, singing, painting or lunch) and customized care and support as required.
Treatment groups
Trial outcomes
Primary outcomes
Short Physical Performance Battery
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Short Phyiscal Performance Battery
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Secondary outcomes
Montreal Cognitive Assessment
The MoCA is a objective instrument, which is designed for milder forms of major neurocognitive disorders, contains 12 items to assess seven cognitive domains: memory, language, executive functions, visuospatial skills, attention, concentration, abstraction, calculation, and orientation. The maximal total score is 30 and higher total score indicate less cognitive impairment. A cut-off score of 26 signifies mild cognitive impairment.
Neuropsychiatric Inventory Questionnaire
The NPI-Q assesses psychopathological problems and is designed to be a self-administered questionnaire completed by caregivers. The questionnaire screening symptom severity and caregiver distress of the following 12 domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour, night-time behaviour disturbance, and appetite and eating abnormalities. The symptom severity scale ranging from 1 to 3. The caregiver distress scale ranging from 0 to 5. The NPI total score is calculated by multiplying the frequency and severity rates per domain and adding them up. The total score ranges from 0 to 144, with higher score indicating hight severity and higher distress.
Cornell Scale for Depression in Dementia
The observation based CSDD, in the form of an interview with the caregiver assesses symptoms of depression. The CSDD consists of 19 items and each one is scored on a 3-point scale ranging from 0 to 2. Items are clustered into five categories: mood, behavioural disturbance, physical signs, cyclic functions, and ideational disturbance. The maximum score is 38, and higher score indicating more depressive symptoms.
Quality of Life in Alzheimer's
The QOL-AD is a brief, 13-item which assesses individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. It is designed to acquire a rating of the patient's Quality of Life from both the patient and the caregiver. It uses simple and straightforward language and responses and includes assessments of the caregivers complete the measure as a questionnaire about their patients' QOL, while patients complete it in interview format about their own QOL. The 13 items are rated on a four-point Likert scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52. The sum of all items; patient and caregiver reports can be evaluated separately and/or combined into a single score if desired.
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