Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Traininng Concept for Older Adults With Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Feasibility - recruitment (absolute)
研究概览
简要总结
The primary objective of this pilot study is to evaluate the feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) of a newly developed exergame-based intervention concept for older adults with mNCD. As a secondary objective, preliminary effects of the intervention on cognition, brain resting-state functional connectivity, gait, cardiac autonomic regulation, and psychosocial factors (i.e. quality of life, and levels of depression, anxiety, and stress) will be explored. This allows to synthesize data for a sample size calculation on basis of a formal power calculation for a future RCT.
A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) pilot randomized controlled study with an allocation ration of 2 : 1 (i.e. intervention : control) including 17 - 25 older adults with mNCD will be conducted between June and December 2021. The active control group will proceed with usual care as provided by the memory clinics where the patients are recruited. The intervention group will perform a twelve-week training intervention according to a newly developed exergame-based intervention concept in addition to usual care. Primary outcomes will be assessed throughout the training intervention period. The measurements of all secondary outcomes will be conducted at ETH Hönggerberg within two weeks prior to starting (PRE) and after completing (POST) the study intervention.
详细描述
After recruitment, interested subjects will be screened on eligibility between July and September 2021. All potential subjects will be fully informed about the study procedures by providing verbal explanations and an information sheet. Expected effects, benefits and risks of the study will be explained by the investigator, who will also be available to answer open questions and clarify uncertainties of participants. It will further be verified, that withdrawal is permitted at any time during the study without giving any reason. After sufficient time for considerations, suitable patients willing to take part in the study will provide written informed consent prior to any measurements and the first study appointment will be scheduled. At the first scheduled appointment, pre-measurements (PRE) will be performed. Thereafter, participants will be randomly allocated to the intervention group (i.e. 'exergame group') or active control group (i.e. 'usual care'). Subsequently, participants in the exergame group will be familiarized with the exergame training system 'Dividat Senso' (Dividat AG, Schindellegi, Switzerland; CE certification), and the study intervention will be started according to the newly developed exergame-based intervention concept. After completing the twelve-week training intervention, post-measurements (POST) will be performed for both groups. Both, the pre- and the post-measurements will take place and within two weeks prior to starting or after completing the intervention.
INTERVENTIONS:
Usual Care:
An active control group will proceed with usual care as provided by the memory clinics where the patients are recruited.
Exergame Group:
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 outcome evaluator of the pre- and post-measurements will be blinded to group allocation. For all data assessed throughout the intervention period (i.e. only applicable for the intervention group), blinding of investigators is not possible. Blinding of participants was also not possible since usual care will be used as a control intervention.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Group 1 = mNCD) clinical diagnosis of 'Mild Neurocognitive Disorder' (mNCD) according to the International Classification of Diseases 11th Revision (ICD-XI) OR (Group 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, while (b2) not falling below the cut-off score for dementia (i.e. < 45/100), while (c) activities of daily living remain intact.
- •fully vaccinated against coronavirus (SARS-CoV-2) with a Federal Office of Public Health (FOPH)-approved mRNA vaccine
- •German speaking
- •age ≥ 50 years
- •able to stand at least for 10 min without assistance
排除标准
- •mobility impairments (i.e. gait, balance) that prevent experiment participation
- •presence of additional 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 Covid-19 specific exclusion criteria (according to the Federal Office of Public Health):
- •high blood pressure (self-reported; systolic ≥ 140 mmHg and/or Diastolic ≥ 90 mmHg)
- •Chronic respiratory condition
- •Condition or therapy that weakens the immune system
- •Cardiovascular Disease
- •Cancer (present and/or under treatment)
- •Serious obesity (BMI ≥ 40 kg/m2)
结局指标
主要结局
Feasibility - recruitment (absolute)
时间窗: Through recruitment completion, an average of 12 weeks.
recruitment rate (absolute) \[\] = number of eligible participants recruited per month
Feasibility - adherence
时间窗: Through recruitment completion, an average of 12 weeks.
adherence rate \[%\] = total number of training sessions attended / total number of training sessions offered
Feasibility - compliance
时间窗: Through recruitment completion, an average of 12 weeks.
compliance rate \[%\] = total training duration attended \[min\] / total training duration offered \[min\]
Usability
时间窗: System Usability is assessed in the Exergame Group at week 6 of the study intervention.
Usability will be assessed on basis of the validated German version of the System Usability Scale (SUS-DE). The SUS-DE is assessed in week 6 of the exergame-based intervention. It consists of ten items that are rated on a five-point Likert scale (i.e. ranging from 1 - "strongly disagree" to 5 - "strongly agree"). A total score will be calculated according to the scoring guidelines of the SUS. The total SUS score ranges between 0 and 100, whereas higher scores indicate better usability. A total SUS score of at least 70 will be considered an "acceptable" solution (i.e. 52 = ok, 73 = good, 85 = excellent, 100 = best imaginable).
Acceptance - enjoyment
时间窗: Through recruitment completion, an average of 12 weeks.
Enjoyment of the exergame-based intervention concept will be assessed on basis of the Exergame Enjoyment Questionnaire (EEQ) that will be translated to German according to the guidelines for the process of cross-cultural adaptation of self-report measures. It consists of 20 statements corresponding to four categories of questions: (1) immersion, (2) intrinsically rewarding activity, (3) control, and (4) exercise. Each statement will be responded to on a five-point Likert scale (i.e. strongly disagree (1 point), disagree (2 points), neutral (3 points), agree (4 points), and strongly agree (5 points). The EEQ will be analyzed by calculating the average overall score as well as an average score for each category of questions.
Feasibility - recruitment (relative)
时间窗: Through recruitment completion, an average of 12 weeks.
recruitment rate (relative) \[%\] = number of screened people / number of enrolled participants
Acceptance - motivation
时间窗: Through recruitment completion, an average of 12 weeks.
The quality (of type) and quantity (of level) of training motivation will be assessed using of the German version of the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3) that is a widely used, valid and reliable measure of the continuum of motivation for exercise in different areas. It consists of 24 items assessing behavioral regulation in exercise contexts on a 5- point Likert scale ranging from 0 = 'not true for me' to 4 = 'very true for me'.
Feasibility - attrition
时间窗: Through recruitment completion, an average of 12 weeks.
attrition rate = number of drop-outs / number of enrolled participants
Acceptance - perceived usefulness
时间窗: Through recruitment completion, an average of 12 weeks.
Perceived usefulness will be evaluated on basis of patient-interviews, organized as semi-structured interviews along a predefined interview guide.
次要结局
- Changes in Learning and Memory - Part 2(Both, the pre- and the post-measurements of secondary outcome measurements will take place and 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 secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Complex Attention - Part 3(Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Psychosocial Factors - Part 2(Both, the pre- and the post-measurements of secondary outcome measurements will take place and 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 secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Brain Functional Connectivity(Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Learning and Memory - Part 1(Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Global Cognition(Both, the pre- and the post-measurements of secondary outcome measurements will take place and 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 secondary outcome measurements will take place and 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 secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Perceptual-Motor Function(Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Psychosocial Factors - Part 1(Both, the pre- and the post-measurements of secondary outcome measurements will take place and 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 secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Executive Function - Part 4(Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
- Changes in Spatiotemporal Gait Parameters(Both, the pre- and the post-measurements of secondary outcome measurements will take place and 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 secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.)
研究者
Eling DeBruin
Prof. Dr.
Swiss Federal Institute of Technology