CybeR-human systEms for perSonalIzed mentaL and physIcal wEll-beiNg and Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Distance traveled
研究概览
简要总结
The purpose of the present study is to evaluate the effectiveness of using multi-parameter monitoring devices in the elderly to improve their quality of life not already understood as the absence of disease but in a logic that is intrinsically linked to the body-mind relationship, which is increasingly significant as biological age advances. The study will be conducted on a sample of volunteer elderly subjects who will wear devices capable of constantly monitoring vital parameters such as heart rate, physical activity, sleep quality, stress levels and higher level activities, linked sensory and cognitive aspects ecologically integrated with the elderly person's living environment, in the sense of an evaluative and qualitative focus on relationships within the person's area of action/interaction, possibly supported and stimulated by individualized and easily usable activities. The signals interpreted and returned by the technology to the elderly person who uses it can also act as a reassuring self-assessment of even normal body states, sometimes experienced as threatening and anxiogenic, thus stressful. The collection and management of these data may serve as a reference to the recognition of distress signals and complex experiences (e.g., depressive) that normally have significant effects on mental health, understood as intrinsically linked to the health of the body.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male and female aged 60 years and older
- •signing of informed consent
排除标准
- •chronic diseases
- •cardiovascular disease
- •presence of dementia and/or depression
- •presence of confirmed paranoid or psychotic symptoms
结局指标
主要结局
Distance traveled
时间窗: Through study completion, an average of 1 year
This indicates the actual physical length each subject covered during activity. It's usually measured in miles or kilometers. Distance traveled can be calculated based on the number of steps you take and your stride length (the distance between two consecutive footfalls with the same foot).
Heart Rate(HR)
时间窗: Through study completion, an average of 1 year
The chest strap Polar H10 uses an electrocardiogram (ECG) sensor to detect the electrical activity of the heart and calculate heart rate in beats per minute (bpm).
Heart rate variability (HRV)
时间窗: Through study completion, an average of 1 year
The chest strap Polar H10 measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms).
Steps taken
时间窗: Through study completion, an average of 1 year
This refers to the total number of times each subject take a step with either foot. It's a basic unit to measure overall activity level. Fitness trackers typically use steps to monitor movement throughout the day.
Facial emotion recognition
时间窗: Through study completion, an average of 1 year
The smartphone's camera records facial expressions in order to evaluate and quantify human emotions. The Artificial Intelligence (AI) algorithms, recognizing the human face, identify important facial features and examine them to categorize different facial emotions. The emotions associated with these facial expressions are then extracted.
Calories burned
时间窗: Through study completion, an average of 1 year
This refers to the amount of energy each subject's body expends during activity. It's measured in calories (kcal). The number of calories burned depends on various factors like weight, height, activity intensity (e.g., walking vs running), and duration. Fitness trackers typically estimate calorie burn based on steps taken, distance traveled, and personal information.
次要结局
未报告次要终点
研究者
Gennaro Tartarisco
Head of Unit
Istituto per la Ricerca e l'Innovazione Biomedica