Exergaming Revolution in Dementia

Официальное название

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.

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Exergaming on Dividat Senso
  The 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.
• Другое Usual Care
  Standardised 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.

Первичные конечные точки

• Short Physical Performance Battery [Срок оценки: Baseline]
• Short Phyiscal Performance Battery [Срок оценки: after 12 weeks]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Sonnweid AG — Wetzikon

Публикации

• Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016. PMID 12021425
• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available. PMID 1202204
• Bellettiere J, Lamonte MJ, Unkart J, Liles S, Laddu-Patel D, Manson JE, Banack H, Seguin-Fowler R, Chavez P, Tinker LF, Wallace RB, LaCroix AZ. Short Physical Performance Battery and Incident Cardiovascular Events Among Older Women. J Am Heart Assoc. 2020 Jul 21;9(14):e016845. doi: 10.1161/JAHA.120.016845. Epub 2020 Jul 14. PMID 32662311
• Cassidy B, Arena S. The Short Physical Performance Battery as a Predictor of Functional Decline. Home Healthc Now. 2022 May-Jun 01;40(3):168-169. doi: 10.1097/NHH.0000000000001070. No abstract available. PMID 35510973
• Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8. PMID 3337862
• Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s. PMID 9153155
• Lindbergh CA, Dishman RK, Miller LS. Functional Disability in Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2016 Jun;26(2):129-59. doi: 10.1007/s11065-016-9321-5. Epub 2016 Jul 8. PMID 27393566
• Sanford AM. Mild Cognitive Impairment. Clin Geriatr Med. 2017 Aug;33(3):325-337. doi: 10.1016/j.cger.2017.02.005. Epub 2017 May 17. PMID 28689566

Идентификаторы

NCT: NCT06631742 · 2024-00113.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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