Effectiveness of an Individualized Exergame-based Motor-Cognitive Training Concept Targeted to Improve Cognitive Functioning in Older Adults With Mild Neurocognitive Disorder - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Changes in Global Cognition
研究概览
简要总结
BACKGROUND:
Simultaneous motor-cognitive training interventions are considered promising to prevent the decline in cognitive functioning in older adults with mild neurocognitive disorder (mNCD) and can be highly motivating when applied in form of exergames.
OBJECTIVES:
This study systematically explores the effectiveness of a newly developed exergame-based motor-cognitive training concept (called 'Brain-IT') targeted to improve cognitive functioning in older adults with mNCD.
METHODS:
A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) randomized controlled trial with an allocation ration of 1 : 1 (i.e. intervention : control) including 34 - 40 older adults with mNCD will be conducted between May 2022 and December 2023. The control group will proceed with usual care as provided by the (memory) clinics where the patients are recruited while the intervention group will perform a twelve-week training intervention according to the newly developed 'Brain-IT' exergame-based training concept in addition to usual care. As a primary outcome, global cognitive functioning will be assessed using the Quick Mild Cognitive Impairment Screen (Qmci). As secondary outcomes, domain-specific cognitive functioning, brain structure and function, spatiotemporal parameters of gait, instrumental activities of daily living, psychosocial factors (e.g. quality of life, and levels of depression, anxiety, stress), and cardiac vagal modulation (heart rate variability at rest) will be assessed. Both, the pre- and the post-measurements will take place within two weeks prior to starting or after completing the intervention.
详细描述
BACKGROUND:
Simultaneous motor-cognitive training interventions are considered promising to prevent the decline in cognitive functioning in older adults with mild neurocognitive disorder (mNCD) and can be highly motivating when applied in form of exergames. To ameliorate the effectiveness of exergaming, the neurobiological mechanisms as well as the most effective components for exergame interventions remain to be established. Besides establishing the most effective components [i.e., qualitative (e.g., type and content of training) and quantitative (e.g., frequency, intensity/complexity, session duration, intervention dose and adaptation over time) exercise and training variables] of exergames for cognition, it is crucial to also account for the users' perspective when designing and developing novel exergames or training concepts.
On this basis, a novel exergame-based training concept (called the 'Brain-IT' exergame-based training concept) was developed specifically for older adults with mNCD with the aim to halt and/or reduce cognitive decline and improve quality of life in older adults with mNCD. This exergame-based training concept has been developed on basis of a structured, iterative, and evidence-based approach based on a theoretical framework - The 'Multidisciplinary Iterative Design of Exergames (MIDE): A Framework for Supporting the Design, Development, and Evaluation of Exergames for Health'. The 'Brain-IT' exergame-based training concept represents a guideline for applying exergame-based motor-cognitive training by standardizing the training characteristics (e.g. training frequency, duration), as well as the structure and content of the training, whereas the exergame device and the games used within each of the defined neurocognitive domains can be replaced at will by alternative exergames. In this study, our training concept is implemented using the 'Senso (Flex)' (Dividat AG, Schindellegi, Switzerland), because this training device is already widely used for motor-cognitive training within geriatric populations, physiotherapies or in rehabilitation in Switzerland and was found to be suitable to implement our training concept. A step-by-step explanation of our methodological approach including the basis for the decision for the design of the exergame-based training concept as well as the complete 'Brain-IT' exergame-based training concept with sufficient details to allow full replication has been published as a methodological paper (doi: 10.3389/fnagi.2021.734012). The 'Brain-IT' exergame-based training concept has already been tested in a pilot randomized controlled trial and has shown good results in feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) (unpublished work; NCT04996654). Based on the findings of this study, some minor modifications were incorporated to optimize the training concept so that it can be applied in a larger sample of patients to be evaluated on its effectiveness to halt and/or reduce cognitive decline and improve quality of life in older adults with mNCD.
OBJECTIVES & HYPOTHESES:
This study explores the effectiveness of the 'Brain-IT' training to improve global cognitive func-tioning in older adults with mNCD. With this, we aim to get a sufficiently precise estimate of the treatment effect to minimize the sample needed for a future full-scale RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will be conducted as a single-blinded study: the outcome evaluator of the pre- and post-measurements will be blinded to group allocation. Blinding of participants will not be possible since usual care will be used as a control intervention.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •(1 = mNCD) clinical diagnosis of 'Mild Neurocognitive Disorder' according to the International Classification of Diseases 11th Revision (ICD-XI) or the Diagnostic and statistical manual of mental disorders (DSM-5®)) OR (2 = sMCI) patients screened for mild cognitive impairment (sMCI) according to the following criteria: (a) informant (i.e. healthcare professionals)-based suspicion of MCI confirmed by (b) an objective screening of MCI based on the German Version of the Quick Mild Cognitive Impairment Screen with (b1) a recommended cut-off score for cognitive impairment (MCI or dementia) of < 62/100 (doi: 10.3233/JAD-161204), while (b2) not falling below the cut-off score for dementia (i.e. < 45/100 (doi: 10.3233/JAD-161204)).
- •German speaking
- •able to stand at least for 10 min without assistance
排除标准
- •The presence of any of the following exclusion criteria will lead to exclusion of the participants:
- •mobility impairments (i.e. gait, balance) that prevent experiment participation
- •presence of additional, clinically relevant (i.e. acute and/or symptomatic) neurological disorders (i.e. epilepsy, stroke, multiple sclerosis, Parkinson's disease, brain tumors, or traumatic disorders of the nervous system)
- •presence of any other unstable or uncontrolled diseases
- •Additional exclusion criteria will comprise of Covid-19 specific exclusion criteria (according to the Federal Office of Public Health). In case of Covid-19 specific exclusion criteria, participation in the study will only be allowed in case the treating physician provided written informed consent to allow participation in this study despite the presence of Covid-19 specific exclusion criteria. These Covid-19 specific exclusion criteria will include:
- •high blood pressure (self-reported; systolic ≥ 140 mmHg and/or Diastolic ≥ 90 mmHg)
- •Chronic respiratory condition
- •uncontrolled type 2 Diabetes
- •Condition or therapy that weakens the immune system
- •unstable Cardiovascular Disease
- •Cancer (present and/or under treatment)
- •Serious obesity (BMI ≥ 40 kg/m2)
研究组 & 干预措施
Usual Care
The control group will proceed with usual care as provided by the (memory) clinics where the patients are recruited.
干预措施: Usual Care (Behavioral)
Intervention Group - Exergame Training
Participants in the intervention group will perform a twelve-week training intervention in addition to their usual care (as provided by the (memory) clinics where the patients are recruited). The training intervention will be prescribed according to our newly developed exergame-based training concept (called 'Brain-IT' exergame-based training concept). Our complete 'Brain-IT' exergame-based training concept has recently been published including sufficient details about the exergame components as well as the exercise and training characteristics (i.e. including all predefined levels of task demands as well as the detailed progression rules) to allow full replication (i.e. consider supplementary file 3 of doi: 10.3389/fnagi.2021.734012). This training concept was planned and will be reported using the Consensus on Exercise Reporting Template (CERT; doi: 10.1136/bjsports-2016-096651).
干预措施: Exergame training according to the 'Brain-IT' exergame-based training concept (Behavioral)
结局指标
主要结局
Changes in Global Cognition
时间窗: Both, the pre- and the post-measurements of the primary outcome measurement will take place within two weeks prior to starting or after completing the intervention.
The German Version of the Quick Mild Cognitive Impairment Screen (Qmci) will be used to assess the overall level of cognitive functioning of the study population (doi: 10.1007/978-3-319-44775-9\_12). Although being a screening instrument, the Qmci was shown to be equally sensitive with similar responsiveness to change over time as compared to the ADAS-Cog (which is considered the gold standard for assessing the efficacy of antidementia treatments) (doi: 10.3233/JAD-170991 and 10.3233/JAD-170991). The Qmci can be completed within 3 - 5 minutes and is scored as a point rate out of a maximum score of 100. It comprises six subtests: orientation (10 points), registration (5 points), clock drawing (15 points), delayed recall (20 points), verbal fluency (20 points), and logical memory (30 points). The Qmci will be administered according to the guidelines provided by O'Caoimh and Molloy in 2017 (doi: 10.1007/978-3-319-44775-9\_12).
次要结局
- Changes in Learning and Memory - Part 1(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Complex Attention - Part 2(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Executive Function - Part 1(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Learning and Memory - Part 2(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Complex Attention - Part 1(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Structure and Function - Part 1 (Grey Matter Volumes)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Structure and Function - Part 3 (Mean diffusivity)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 3 (stride length)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Psychosocial Factors - Part 1 (Quality of Life)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Executive Function - Part 2(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Executive Function - Part 3(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Structure and Function - Part 2 (White Matter Volumes)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 2 (stride duration)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 4 (stance phase duration)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Instrumental Activities of Daily Living (IADL)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Visuospatial Skills(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 1 (single-task gait speed at preferred walking speed)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 5 (swing time)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 6 (single support time)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters - Part 6 (double support time)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Psychosocial Factors - Part 2 (Symptoms of Depression)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Structure and Function - Part 4 (Fractional Anisotropy)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Structure and Function - Part 5 (Functional Connectivity Maps at rest)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Structure and Function - Part 6 (Functional Connectivity Maps during an episodic memory-task)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
- Changes in vagally-mediated Heart Rate Variability (HRV)(Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.)
研究者
Eling DeBruin
Prof. Dr.
Swiss Federal Institute of Technology