Exergaming Revolution in Dementia
- Conditions
- Major Neurocognitive DisorderAlzheimer DiseaseParkinson DiseaseLewy Body DementiaMixed Dementias
- Interventions
- Other: Exergaming on Dividat SensoOther: Usual Care
- Registration Number
- NCT06631742
- Lead Sponsor
- Eastern Switzerland University of Applied Sciences
- Brief Summary
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.
- Detailed Description
Background: Major neurocogntivie disorders (MNCD) are categorised as public health priority by the World Health Organisation. To date, there are no disease-modifying treatments that can cure MNCD or effectively halt its progression. However, lifestyle changes that increase physical activity and/or reduce vascular risk factors are effective in protecting against brain atrophy and cognitive decline. Therefore, it has been suggested to focus on non-pharmacological therapies that target people\'s lifestyle, such as multimodal treatment strategies that encompass multiple domains, including physical exercise and cognitive stimulation. Exergames which combine exercise with feedback on performance, fun, relaxation and socialising, are promising for older people.
The goal of this pilot randomized controlled trial is to evaluate the effect of an exergaming intervention in people with MNCD. The main questions it aims to answer are:
* How does an exergaming intervention effects gait speed, cognitive and motor functions as well as depressive symptoms and quality of life in residents of a long-term care facilities.
* How does an exergaming intervention effects physical activity and sleep in residents of a long-term care facilities.
Methods: Investigators plan to include 48 participants living in long-term care facilities. Participants will participate in a 12 weeks active dance video game (3x 15minute per week) or will get care as usual. The Short Physical Perfomance Battery (SPPB), The Montréal Cognitive Assessment (MoCA), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Quality of Life in Alzheimer\'s (QoL-AD), Katz activities of daily living (Katz-ADL), Geriatric Sleep Questionnaire (GSQ-6), number\'s of falls in the last 12 weeks, physical activity and sleep parameters of the motions sensor GENEactiv and sleep parameters of the contacless sensorbox Sleepiz are measured at baseline and post intervention.
For all outcomes, descriptive statistics will be computed first. Normality distribution of data will be checked using the Shapiro-Wilk test and Q-Q-plots. The assumptions of homogeneity of variance and of sphericity will be checked using Levene's test and Mauchly's test, respectively. In case all assumptions are met, a two-way analysis of covariance (ANCOVA) will be computed for all primary and secondary outcomes with the pre-test as covariate for the predicting group factor and the posttest as outcome variable. Therefore, the outcome is the differences of the pre- and post-test with the baseline as the influencing variable. In case not all assumptions for ANCOVA are met, Quade non-parametric tests will be used. The level of significance will be set to p ≤ 0.05 (two-sided).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exergaming Exergaming on Dividat Senso Individual active dance game training on Dividat Senso Usual Care Usual Care Customised care and support as required
- Primary Outcome Measures
Name Time Method Short Physical Performance Battery Baseline 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 after 12 weeks 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 Outcome Measures
Name Time Method Montreal Cognitive Assessment Baseline, after 12 weeks 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 Baseline, after 12 weeks 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 Baseline, after 12 weeks 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 Baseline, after 12 weeks 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.
Katz ADL Baseline, after 12 weeks The interviewer-administered Katz ADL Index assesses participants' function in terms of level of independence or dependence when performing certain daily living activities. It consists of six items: bathing, dressing, transfers, toileting, continence, and feeding. Each item is scored 0 (dependence) or 1 (independence) with a maximum score of 6, which indicates more independence.
Geriatric Sleep Questionnaire Baseline, after 12 weeks Self-reported Questionnaire assesses overall sleep quality. Item score are summed up with the maximal total score of 30. Higher score indicate poorer sleep quality.
Numbers of falls in the last 12 weeks Baseline, after 12 weeks Numbers of Falls during 12 weeks prior to baseline and during the 12 weeks to follow up according to the patient's medical record will be assessed.
Motion Sensor GENEactiv Basline, after 12 weeks GENEActiv is a lightweight and waterproof medical device that delivers continuous recording of high-resolution acceleration that allows a person's daily activities to be classified, second by second, in terms of the time spent lying, sitting, standing, stepping and sleep parameters such as total sleep time, sleep efficiency and body temperature (e.g., circadian rhythm).
Contactless Sensorbox Sleepiz Baseline, after 12 weeks Radar-based contactless technology measuring body position and respiratory rate.
Trial Locations
- Locations (1)
Sonnweid AG
🇨🇭Wetzikon, Zurich, Switzerland