TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity

Study Overview
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Brief Summary
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Physical inactivity is a major public health issue. Prescription of physical activity appears necessary in some situation with cardiovascular risk. It is important to both qualify and quantify daily physical activity. The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt) performance in 12 healthy subjects, wearing this system over the daytime during one week.

Detailed Description
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Healthy subjects have to make different physical activities, wearing the TEMIS system like slow and fast walking, biking, running.

Official Title
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TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity

Conditions
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Healthy, Sedentary

Intervention / Treatment
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* Device: TEMIS system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18 - 50 yo BMI between 18 and 30 Without chronic disease or chronic treatment (oral contraception is allowed) Normal electrocardiogram Able to do all the specified physical activity requested by the protocol Able to use smart phone and computers With access to WIFI, bicycle, and car Living in the close area Affiliated to public health insurance Exclusion Criteria: Severe allergia Severe skin lesions at the thorax level Not able to use correctly the TEMIS system Will take plane during the week of evaluation Under protection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group using TEMIS system<br>using TEMIS system during physical exercises: walking, biking, running | Device: TEMIS system<br>* Wearing TEMIS system over the day during one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance (kappa score) between actual and estimated physical activity | Investigators will during the seven days of the protocol, when the system TEMIS is hold, evaluate the concordance between the activity really performed by the subject (questionnaire) and the activity calculated by the TEMIS System (Kappa test). Investigators will evaluate the following activity: lying position, sitting position, standing position, walking activity, running activity, bicycle activity, use of a vehicle (car, bus) | One week (average of each day recording) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total duration of recording in hours |  | One week (sum of each day recording) | 
| number of subjects with adverse events | will be considered as adverse events allergia discomfort with removal of the system | one week |