The Cognitive and spOrt Virtual EPIC Training Study: Investigating the Effects of Home-based Exercise and Cognitive Training in Cardiovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in processing speed
研究概览
简要总结
COVEPICARDIO trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults with cardiovascular diseases.
详细描述
Cardiac rehabilitation is a class I level A recommendation with clinical benefits that are now well documented. Due to the COVID-19 pandemic, accessibility to rehabilitation services and exercise training programs are limited. Quarantine measures can induce collateral damages to cardiovascular and psychological health, in particular in clinical population. Cardiovascular diseases (CVD) are associated with cognitive deficits and increased risk of dementia later in life. Specifically for CVD, physical inactivity and excessive sedentary lifestyle induced by confinement decrease cardiorespiratory capacity, increase the risk of acute events and rehospitalization. Maintaining a minimum of physical activity during a health crisis is fundamental. In this context, our team has developed an innovative program of exercise and cognitive training at home. Considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors with CVD, this project also addresses the added benefits of a multidomain intervention combining a home-based physical exercise intervention with a cognitive training.
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50 and older
- •Have access to internet
- •Have access to a tablet (i.e., iPad or Android) or a computer
- •Diagnostic of cardiovascular disease (stable chronic systolic or diastolic heart failure, atrial fibrillation, documented atherosclerotic disease).
- •Able to do light to moderate aerobic exercice training
- •With no contraindication to exercise training
排除标准
- •Non-cardiopulmonary limitation to exercise (e.g., arthritis)
- •Severe exercise intolerance
- •Respiratory disease (e.g., asthma, COPD, COVID-19)
- •Mini Mental Scale Examination (MMSE) telephone version lower than 19/23
研究组 & 干预措施
Multidomain intervention
The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month.
干预措施: Physical exercise training (Behavioral)
Multidomain intervention
The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month.
干预措施: Cognitive training (Behavioral)
Physical exercise intervention
The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month.
干预措施: Physical exercise training (Behavioral)
结局指标
主要结局
Change in processing speed
时间窗: Baseline and post-intervention at 6 months
Validated remote version of Rey auditory verbal learning test, Trail Making Test, as well as Phonological and Semantic Fluency, Similarity, and Digit Span neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory
时间窗: Baseline and post-intervention at 6 months
Validated remote version of Rey auditory verbal learning test, Trail Making Test, as well as Phonological and Semantic Fluency, Similarity, and Digit Span neuropsychological tests and iPad tests (Composite Z-score).
Change in general cognitive functioning
时间窗: Baseline and post-intervention at 6 months
Validated remote version of Montreal Cognitive Assessment
Change in executive functions
时间窗: Baseline and post-intervention at 6 months.
Validated remote version of Rey auditory verbal learning test, Trail Making Test, as well as Phonological and Semantic Fluency, Similarity, and Digit Span neuropsychological tests and iPad tests (Composite Z-score).
次要结局
- Change in Walking speed(Baseline and post-intervention at 6 months.)
- Change in Functional mobility(Baseline and post-intervention at 6 months)
- Change in Cardiorespiratory fitness(Baseline and post-intervention at 6 months)
- Change in Balance performance(Baseline and post-intervention at 6 months)
- Change in Lower limb muscles strength(Baseline and post-intervention at 6 months)
研究者
Louis Bherer
Associate Scientific Director, Direction of Prevention
Montreal Heart Institute