Sensors for HEalth Recording and Physical Activity Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- asses the continuous acquisition of data by sensors
研究概览
简要总结
The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.
详细描述
To assess the SHERPAM Device (DS) by the continuous acquisition and transmission of data (accelerations, rotations, alterations in thoracic volume, heart rate, electrocardiogram) in a real life physical activity practice (subjects in their living environment and during their usual physical practices) using the DS's real-time communication tools, automatic data processing, and the DS's ability to produce information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers Healthy active subjects aged 50 or over (ie without diagnosed disease, without chronic treatment) and recruited in the sports associations of Ille et Vilaine (cycle tourism clubs).
- •having benefited from an oral or written prescription of physical activity carried out by a health professional and applying this prescription daily in autonomy or in a sports club.
- •Common to all subjects
- •physically active (adherent to a club or sports association or practicing independently according to the recommendations of their physician);
- •practicing at least once a week;
- •residence located less than 100 km return from Rennes University Hospital
- •affiliate or beneficiary of a social protection scheme;
- •having given his written consent
排除标准
- •Common to all subjects
- •wearing a pacemaker or implanted cardiac defibrillator (precaution because using telemetry);
- •participation in another research protocol;
- •persons aver 18 yrs-old subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
- •pregnant or nursing woman.
结局指标
主要结局
asses the continuous acquisition of data by sensors
时间窗: every day (during 3 weeks)
transmission and reception of physiological parameters of a patient
次要结局
- Test usability of Sherpam Device(after 21 days of use)
- Test acceptability of Sherpam Device(after 21 days of use)
- Test acceptability of SHERPAM Device(after 7 days of use)