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OpenTrials
Completed

NCT Number: NCT02687659

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

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.

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Key information

Conditions

Healthy Behavior Sedentary Sedentary Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, Maine et Loire, 49933, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEMIS system

Device

Wearing TEMIS system over the day during one week

Primary outcomes

  1. concordance (kappa score) between actual and estimated physical activity

    Time frame: 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 outcomes

  1. total duration of recording in hours

    Time frame: One week (sum of each day recording)

  2. number of subjects with adverse events

    Time frame: one week

    will be considered as adverse events

    • allergia
    • discomfort with removal of the system

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
  • University Hospital, Toulouse

Registry information

Acronym: TEMIS

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 22, 2016
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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