Clinical trial NCT06631742: Exergaming Revolution in Dementia
Official title: The Effect of an Exergaming Intervention on Physical Activity and Sleep in People With Major Neurocognitive Disorders Living in Long-term Care Facilities: a Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Neurocognitive Disorder
Alzheimer Disease
Parkinson Disease
Lewy Body Dementia
Mixed Dementias
Lead sponsor: Eastern Switzerland University of Applied Sciences
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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\&#39;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\&#39;s (QoL-AD), Katz activities of daily living (Katz-ADL), Geriatric Sleep Questionnaire (GSQ-6), number\&#39;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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline
measure: Short Phyiscal Performance Battery
timeFrame: after 12 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Baseline, after 12 weeks
measure: Neuropsychiatric Inventory Questionnaire
timeFrame: Baseline, after 12 weeks
measure: Cornell Scale for Depression in Dementia
timeFrame: Baseline, after 12 weeks
measure: Quality of Life in Alzheimer&#39;s
timeFrame: Baseline, after 12 weeks
measure: Katz ADL
timeFrame: Baseline, after 12 weeks
measure: Geriatric Sleep Questionnaire
timeFrame: Baseline, after 12 weeks
measure: Numbers of falls in the last 12 weeks
timeFrame: Baseline, after 12 weeks
measure: Motion Sensor GENEactiv
timeFrame: Basline, after 12 weeks
measure: Contactless Sensorbox Sleepiz
timeFrame: Baseline, after 12 weeks
Other outcomes:
Locations:
city: Wetzikon
country: Switzerland
facility: Sonnweid AG
state: Zurich
Study officials:
affiliation: Eastern Swiss University of Applied Sciences
name: Eling de Bruin, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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