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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Sedentary
• Intervention / Treatment: Device: TEMIS system

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Maine et Loire
    • Angers, Maine et Loire, France, 49933
      • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group using TEMIS system; using TEMIS system during physical exercises: walking, biking, running	Device: TEMIS system; Wearing TEMIS system over the day during one week

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: University Hospital, Toulouse; MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
• Investigators: Principal Investigator: Marc-Antoine CUSTAUD, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 31, 2014
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 19, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2014-A00444-43