S.M.A.R.T: A Pragmatic Randomised Controlled Trial of Personalized Cognitive-Motor Exergame Training in Frail Community-Dwelling Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Balance
研究概览
简要总结
This international multicentre pragmatic randomized controlled trial (RCT) aims to evaluate the effectiveness of personalized, home-based cognitive-motor training using exergames in improving cognitive and motor functions in frail adults. A total of 344 frail participants from five European countries will be enrolled. Participants in the intervention group will engage in a personalized exergame program, while the control group will follow the Otago Exercise Program. Both groups will undergo 12 weeks of training. The primary outcome is balance, a critical component of functional independence and fall prevention, and a common denominator affected in both physical and cognitive frailty. Secondary outcomes including cognitive and motor fall-risk factors, fall incidence, cost-effectiveness, and psychosocial outcomes.
详细描述
The global population is aging rapidly, with those aged 60+ expected to double by 2050. While longevity is increasing due to better healthcare and living conditions, this shift poses major challenges, frailty being a key concern. Affecting 5%-58% of older adults, frailty compromises independence, quality of life, and healthcare systems. It is a dynamic condition marked by vulnerability to stressors and can appear as physical, cognitive, or combined frailty.
Physical frailty is well-studied, often defined by low gait speed, fatigue, weakness, weight loss, and reduced activity, but broader health indicators are also used. Cognitive frailty, recognized more recently, is defined as the co-existence of physical frailty and cognitive impairment without dementia. It may signal early dementia risk and greater susceptibility to adverse outcomes.
A core feature of frailty is balance dysfunction, caused by impairments in sensory, cognitive, and motor systems. This is especially problematic during dual tasks, like walking while talking, where attention is divided. Such deficits increase fall risk and accelerate cognitive and physical decline.
Traditional fall prevention emphasizes strength and balance, often overlooking cognitive factors. Yet, evidence shows that motor and cognitive systems are linked, and dual-task training can enhance both domains. Cognitive-motor training, which integrates cognitively demanding tasks into physical exercises, offers a promising dual-domain intervention by leveraging shared brain networks and promoting neuroplasticity.
While effective, most cognitive-motor programs are delivered in person and rarely tailored to individual frailty profiles. Personalized, home-based programs could offer better results through tailored challenge and engagement. Exergames, interactive digital games with physical and cognitive components, show promise as customizable, engaging tools for such training. However, few have integrated both domains simultaneously in frail adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •50 years and older
- •Fried Frailty Phenotype score 3 or higher and/or MoCA score between 10-25
- •Must be able to give informed consent
- •Access to internet and a TV/large screen at home
排除标准
- •Mobility limitations (e.g., severe arthritis or lower extremity amputation)
- •Cognitive limitations (e.g., advanced Alzheimer's disease, frontotemporal/Lewy body/vascular dementia)
- •Sensory limitations (e.g., color-blindness, complete hearing loss and neuropathy causing significant loss of sensation)
- •Psychiatric limitations (e.g., acute, or uncontrolled affective disorders)
- •Comorbidities that would impair their ability to engage in the training
- •Simultaneous participation in other clinical trials/intervention studies
- •Inability to understand game instructions and play the games safely, based on judgement of a therapist
研究组 & 干预措施
Intervention Group
Participants in the IG will receive personalized cognitive-motor training in their home environment. The simultaneous cognitive-motor training in this study will be delivered using the exergame platform "Senso Flex" by Dividat (Dividat AG, Schindellegi, Switzerland). The first session will be supervised by an investigator. Afterwards, participants will continue the training independently at home, with remote supervision and guidance. Participants will be recommended to train 5 times per week for 30 minutes in each session over a 12-week period. Weekly game play will be 150 min to help ensure equal doses of training between IG and CG. The training plan for each participant will be tailored to ensure a progressive and personalized approach. Besides, participants of the intervention group will participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (post-intervention, after training period), (3) T3 (follow-up assessment).
干预措施: Personalized, home-based motor-cognitive exergame training (Other)
Control Group
Participants in the CG will receive the evidence-based OEP on fall prevention. Like for the IG, participants of the CG will be recommended to train 5 times per week for 30 minutes in each session. The training will be conducted over a 12-week period, with a total weekly duration of 150 minutes. The first session will be supervised by an investigator. The program will be implemented in the form of a booklet, designed to provide a comprehensive guide for improving balance, strength, and overall physical function. Like the IG, the participants of the control group will also participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (post-intervention, after training period), (3) T3 (follow-up assessment).
干预措施: Otago Exercise Program (Other)
结局指标
主要结局
Balance
时间窗: The primary outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.
The primary outcome measure is balance, which will be assessed by using Berg Balance Scale (BBS). Balance is the ability to maintain stability and control of the body during everyday activities or movements, encompassing both static and dynamic balance. By focusing on balance, the aim is to gain insights into frail adults' ability to remain autonomous and prevent or slow down further frailty-related decline. The BBS has been selected for its proven reliability and validity in assessing balance and predicting fall risk in this population. BBS is a quantitative tool used to assess a patient's ability, or inability, to maintain balance safely during a series of predetermined activities. The scale consists of 14 items, each rated on a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of functional ability and 4 representing the highest.
次要结局
- Dynamic balance(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Lower extremity function(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Functional Mobility and Balance in Single Task(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Functional Mobility and Balance in Dual-Task(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Dual-Task Costs(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Functional capacity(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Performance Fatigability(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Response inhibition (reaction time)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Response inhibition (error rate)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Cognitive flexibility (reaction time)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Cognitive flexibility (error rate)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Psychomotor Speed(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Psychomotor errors(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Sustained attention and response inhibition (reaction time)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Sustained attention and response inhibition (error rate)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Fall incidence(Fall history will be collected at most 1 week prior to starting the intervention. Fall incidence will be collected continuously throughout the intervention, as well as during the 12 weeks post-intervention.)
- Fear of falling(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Quality of life parameters(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Exergame Enjoyment Questionnaire(This outcome will be measured at most 1 week after the end of the intervention.)
- Usability(This outcome will be measured at most 1 week after the end of the intervention.)
- Adherence(This outcome will be recorded continuously throughout the intervention period, namely in the weeks 1, 2 , 3, 5, 7, 9, 11, and 12 of the intervention.)
- Level of assistance(This outcome will be measured at most 1 week before the intervention starts, then continuously throughout the intervention period and again 12 weeks after the end of the intervention.)
- Adverse events(This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.)
- Attrition rate(This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.)
- Dynamic balance(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Lower extremity function(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Functional Mobility and Balance in Single Task(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Functional Mobility and Balance in Dual-Task(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Dual-Task Costs(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Functional capacity(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Performance Fatigability(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Response inhibition (reaction time)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Response inhibition (error rate)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Cognitive flexibility (reaction time)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Cognitive flexibility (error rate)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Psychomotor Speed(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Psychomotor errors(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Sustained attention and response inhibition (reaction time)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Sustained attention and response inhibition (error rate)(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Fall incidence(Fall history will be collected at most 1 week prior to starting the intervention. Fall incidence will be collected continuously throughout the intervention, as well as during the 12 weeks post-intervention.)
- Fear of falling(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Quality of life parameters(This outcome will be measured at most 1 week prior to starting the intervention, one week after finishing the intervention and then again 12 weeks after the end of the intervention.)
- Exergame Enjoyment Questionnaire(This outcome will be measured at most 1 week after the end of the intervention.)
- Usability(This outcome will be measured at most 1 week after the end of the intervention.)
- Adherence(This outcome will be recorded continuously throughout the intervention period, namely in the weeks 1, 2 , 3, 5, 7, 9, 11, and 12 of the intervention.)
- Level of assistance(This outcome will be measured at most 1 week before the intervention starts, then continuously throughout the intervention period and again 12 weeks after the end of the intervention.)
- Adverse events(This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.)
- Attrition rate(This outcome will be measured starting from at most 1 week before the intervention, throughout the intervention until the final measurement 12 weeks after the end of the intervention.)
研究者
Eleftheria Giannouli
Principal Investigator
Swiss Federal Institute of Technology