Frailty Status in Hospitalized Persons: Artificial Intelligence-based Detection and Technology-assisted Home-based Empowerment (ART.I.DE.)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
This project, that lays in Health Ageing mission promoted by European Commission, aims to address the issue of frailty, a condition that poses the elderlies to increased vulnerability, deconditioning, and, ultimately, loss of independence. Frail people are exposed to a significant increase in mortality, hospitalizations and falls, with high burden for families and for the National Health Service (NHS). Nowadays, the detection of frailty is performed with more than 75 validated measures including questionnaires, scales and technologies. Moreover, frailty is usually not properly addressed, due to the limited resources in terms of personnel and programs in the NHS, and the frail patient is at high risk to be institutionalized and to definitely lose his functional independence. The project here proposed aims to address these topics, by combining clinical, rehabilitation, and engineering expertise in a unique team.
Indeed, the projects aims to empower the frail people with an home-based app-guided rehabilitation program. In order to easily develop a largely tested home-based walking program, we aim to design and develop an application, compatible with any device, that will enable each person to easily exercise at home just few minutes per day. Through a randomized-controlled clinical trial, we will verify the effectiveness of the rehabilitation program on frailty status, in promoting patients' independence, quality of life and ARTIDE score.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frail condition as determined by a Fried Frailty Score equal or more than 2,
- •Barthel Index > 60
- •Ability to ambulate also with assistance
- •Ability to communicate with the research team
- •Ability to use a smartphone or a tablet.
排除标准
- •terminal illness;
- •life-threatening conditions;
- •absolute contraindications to exercise training (e.g. fracture);
- •severe cognitive decline identified by a Mini-mental status examination < 18;
- •incapability or unwillingness to provide informed consent.
研究组 & 干预措施
Home-based technology-assisted Exercise
Patients enrolled in this group will undergo an exercise-based intervention at home guided by the ARTIDE app. Each exercise session will encompass 8 walking minutes at home at a fixed slow speed to be repeated twice per day. Every week the speed will be slightly increased to maintain an adequate training stimulus.
干预措施: Home-based walking training (Behavioral)
Control
Patients enrolled in this group will receive usual care, including traditional home rehabilitation, if needed.
结局指标
主要结局
Short Physical Performance Battery
时间窗: From enrollment to the end of treatment at 3 months
This battery includes three different tests focusing on balance (side-by-side, semi-tandem and tandem position), gait speed (4-meter test) and lower-limb strength (5-time sit-to-stand test). The scale score ranges from 0 (lowest) to 12 (higher) by summing the points obtained in the three tests.
次要结局
- Barthel Index(From enrollment to the end of treatment at 3 months)
- 2-minute walking test(From enrollment to the end of treatment at 3 months)
- Quality of life through EQ-5D-5L questionnaire(From enrollment to the end of treatment at 3 months)
- Number of falls(From enrollment to 12 months)
- All-cause hospitalizations(From enrollment to 12 months)
- Survival rate(From enrollment to 12 months)