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

Not Applicable

Completed

• Conditions: Sedentary; Healthy
• Interventions: Device: TEMIS system

• Registration Number: NCT02687659
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-31
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-19
• Last Update Submitted: 2016-02-19
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group using TEMIS system	TEMIS system	using TEMIS system during physical exercises: walking, biking, running

Primary Outcome Measures

Name	Time	Method
concordance (kappa score) between actual and estimated physical activity	One week (average of each day recording)	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)

Secondary Outcome Measures

Name	Time	Method
total duration of recording in hours	One week (sum of each day recording)
number of subjects with adverse events	one week	will be considered as adverse events; * allergia; * discomfort with removal of the system

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, Maine et Loire, France