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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02687659
Acronym
TEMIS
Enrollment
12
Registered
2016-02-22
Start date
2014-05-31
Completion date
2015-01-31
Last updated
2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Sedentary

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.

Interventions

DEVICETEMIS system

Wearing TEMIS system over the day during one week

Sponsors

University Hospital, Toulouse
CollaboratorOTHER
MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
CollaboratorUNKNOWN
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
concordance (kappa score) between actual and estimated physical activityOne 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

MeasureTime frameDescription
total duration of recording in hoursOne week (sum of each day recording)
number of subjects with adverse eventsone weekwill be considered as adverse events * allergia * discomfort with removal of the system

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026