Sensors for HEalth Recording and Physical Activity Monitoring

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sensors for HEalth Recording and Physical Activity Monitoring

Conditions
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Physical Activity

Intervention / Treatment
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* Device: sensors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, monocentric, with healthy volunteers and patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>Sensors assigned for 3 weeks | Device: sensors<br>* Acquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio.<br>|
| Experimental: Patients with arythmic disease or peripheral vascular disease<br>Sensors assigned for 3 weeks | Device: sensors<br>* Acquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asses the continuous acquisition of data by sensors | transmission and reception of physiological parameters of a patient | every day (during 3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test acceptability of SHERPAM Device | questionnary | after 7 days of use | 
| Test acceptability of Sherpam Device | questionnary | after 21 days of use | 
| Test usability of Sherpam Device | questionnary | after 7 days of use | 
| Test usability of Sherpam Device | questionnary | after 21 days of use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensors, Health Recording