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

Healthy Clinical Trial

— TEMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687659
• Other study ID #: 2014-A00444-43
• Status: Completed
• Phase: N/A
• First received: May 31, 2014
• Last updated: February 19, 2016
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy
• Sedentary

Intervention

Device:
• TEMIS system
Wearing TEMIS system over the day during one week

Locations

Country	Name	City	State
France	CHU Angers	Angers	Maine et Loire

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	total duration of recording in hours		One week (sum of each day recording)	No
Secondary	number of subjects with adverse events	will be considered as adverse events; allergia; discomfort with removal of the system	one week	Yes

External Links

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