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

NCT ID: NCT02687659

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-01-31

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.

Conditions

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Healthy Sedentary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group using TEMIS system

using TEMIS system during physical exercises: walking, biking, running

Group Type EXPERIMENTAL

TEMIS system

Intervention Type DEVICE

Wearing TEMIS system over the day during one week

Interventions

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TEMIS system

Wearing TEMIS system over the day during one week

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role collaborator

MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse

UNKNOWN

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc-Antoine CUSTAUD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CHU Angers

Angers, Maine et Loire, France

Site Status

Countries

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France

Other Identifiers

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2014-A00444-43

Identifier Type: -

Identifier Source: org_study_id

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