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Clinical Trials/NCT06631742
NCT06631742
Recruiting
N/A

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.

Eastern Switzerland University of Applied Sciences1 site in 1 country48 target enrollmentSeptember 27, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Major Neurocognitive Disorder
Sponsor
Eastern Switzerland University of Applied Sciences
Enrollment
48
Locations
1
Primary Endpoint
Short Physical Performance Battery
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 27, 2024
End Date
April 30, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eastern Switzerland University of Applied Sciences
Responsible Party
Principal Investigator
Principal Investigator

Eling de Bruin

Prof. Dr. Eling de Bruin

Eastern Switzerland University of Applied Sciences

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

  • 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

Outcomes

Primary Outcomes

Short Physical Performance Battery

Time Frame: 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

Time Frame: 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 Outcomes

  • Montreal Cognitive Assessment(Baseline, after 12 weeks)
  • Neuropsychiatric Inventory Questionnaire(Baseline, after 12 weeks)
  • Cornell Scale for Depression in Dementia(Baseline, after 12 weeks)
  • Quality of Life in Alzheimer's(Baseline, after 12 weeks)
  • Katz ADL(Baseline, after 12 weeks)
  • Geriatric Sleep Questionnaire(Baseline, after 12 weeks)
  • Numbers of falls in the last 12 weeks(Baseline, after 12 weeks)
  • Motion Sensor GENEactiv(Basline, after 12 weeks)
  • Contactless Sensorbox Sleepiz(Baseline, after 12 weeks)

Study Sites (1)

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