Prevention of Cognitive Decline and Falls With Dalcroze Eurhythmics and a Simple Home Exercise Strength Program for Seniors With Subjective Cognitive Decline (SCD) - MOVE for Your MIND
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Change in cognitive function
研究概览
简要总结
Among the most promising interventions targeting both cognitive and functional decline, is Exercise. However, evidence regarding exercise interventions among seniors with cognitive impairment are inconclusive, likely due to challenges of recruitment and adherence. Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting objective criteria of cognitive impairment, but have been shown to have twice the conversion rate to dementia compared with healthy seniors, are more likely to be motivated to participate and adhere to exercise interventions. Thus, exercise interventions in seniors with SCD may provide a window of opportunity for early prevention of dementia and falls.
The investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze Eurhythmics) and a simple home strength exercise program on change of cognitive function and the rate of falling among seniors with SCD.
详细描述
In Europe and in Switzerland, the number of seniors age 70 and older is predicted to increase from 25% to 40% by 2030, as is the number of seniors with cognitive impairments, physical frailty and resulting consequences, such as falls and loss of autonomy. One out of three seniors age 65 and one out of two seniors age 80 experience at least one fall per year. Prevalence of dementia increases with age and more than doubles a seniors' risk of falling.
Among the most promising interventions targeting both cognitive and functional decline, is Exercise. However, evidence regarding exercise interventions among seniors with cognitive impairment are inconclusive, likely due to challenges of recruitment and adherence. Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting objective criteria of cognitive impairment, but have been shown to have twice the conversion rate to dementia compared with healthy seniors, are more likely to be motivated to participate and adhere to exercise interventions. Thus, exercise interventions in seniors with SCD may provide a window of opportunity for early prevention of dementia and falls.
The investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze Eurhythmics) and a simple home strength exercise program on change of cognitive function and the rate of falling among seniors with SCD.
The MOVE for your MIND trial will be a single center, single-blinded randomized controlled clinical trial among 195 senior men and women and a 12 month follow-up. Participants will be community-dwelling seniors, age 70+ who meet the criteria for SCD without evidence for objective cognitive impairment. The 3 treatment arms are: (1) Jaques-Dalcroze Eurhythmics group exercise (1x60min/week), (2) simple home exercise strength program (3x30min/week), (3) control group without exercise intervention. All participants will receive a monthly "Healthy Nutrition" lecture. The hypothesis is that both exercise groups are superior to control. Under these assumptions, and a sample size of 195 seniors, the investigators will have >90% power for change in cognitive function and >80% power for the difference in the rate of falls. Clinical visits will be at baseline, 6 months, and 12 months. Therapeutic interventions for seniors with early subjective signs of cognitive decline that are effective, affordable, and well-tolerated in the prevention of both, cognitive and physical function decline, are urgently needed and will have an outstanding impact on public health as a whole. To the investigator's knowledge, this is the first exercise trial to target seniors with SCD and with the change in cognitive function and the rate of falls as the primary endpoints. Providing an evidence-base for a group- and a home-based exercise will give a choice to patients. Further, the mechanistic biomarker study for brain and muscle health among seniors with SCD will support the findings at the cellular level and whole-brain MRI imaging will support them at a structural level.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 70+, living in the community
- •Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire
排除标准
- •Signs of mild cognitive impairment (MCI), MoCA score ≤24
- •Score of ≥5 on the short form of the Geriatric Depression Scale (15items)
- •Inability to walk or to come to the study entre
- •Severe gait impairment or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope, heavy alcohol consumption)
- •Currently engaged in regular (once a week or more) strength training instructed by a professional teacher and including the explicit aim to improve muscle strength, or regular (once a week or more) Dalcroze eurhythmics classes
- •Active cancer or current cancer treatment
- •Inability to read and/or speak German necessary to understand the instructions
结局指标
主要结局
Change in cognitive function
时间窗: 12 months
assessed with the CERAD-plus test
Rate of falls
时间窗: 12 months
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
次要结局
- Cognitive function: Word List Recognition(12 months)
- Proportion of seniors with any falls and injurious falls(12 months)
- Cognitive function: Mini Mental State Exam(12 months)
- Cognitive function: verbal fluency test(12 months)
- Rate of injurious falls(12 months)
- Cognitive function: Boston Naming test(12 months)
- Cognitive function: Phonematic Fluency Test(12 months)
- Incident MCI(12 months)
- Cognitive function: Constructional Praxis Recall(12 months)
- Functional decline: repeated sit-to-stand test(12 months)
- Change in gait variability under single task condition(12 months)
- Quality of life: RAND 36-Item Short Form Survey(12 months)
- Changes in biomarkers of inflammation: hr-CRP(12 months)
- Cognitive function: Trial Making Test A(12 months)
- Functional decline: gait speed(12 months)
- Cognitive function: Trial Making Test B(12 months)
- Cognitive function: Word List Learning(12 months)
- Cognitive function: Word List Recall(12 months)
- Functional decline: timed up and go test(12 months)
- Quality of life: EuroQuol(12 months)
- Changes in biomarkers of inflammation: IL-6(12 months)
- Cognitive function: Constructional Praxis(12 months)
- Functional decline: short physical performance battery(12 months)
- Change in gait variability under dual task condition(12 months)
- Changes in IGF-1(12 months)
- Mental Health: Geriatric Depression Scale(12 months)
- Functional decline: grip strength(12 months)