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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Short Physical Performance Battery
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Eling de Bruin
Prof. Dr. Eling de Bruin
Eastern Switzerland University of Applied Sciences