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

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ClinicalTrials.gov Identifier: NCT02687659
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Collaborators:
University Hospital, Toulouse
MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
Information provided by (Responsible Party):
University Hospital, Angers

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.


Condition or disease Intervention/treatment Phase
Healthy Sedentary Device: TEMIS system Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687659


Locations
France
CHU Angers
Angers, Maine et Loire, France, 49933
Sponsors and Collaborators
University Hospital, Angers
University Hospital, Toulouse
MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
Investigators
Principal Investigator: Marc-Antoine CUSTAUD, MD, PhD University Hospital, Angers

Additional Information:
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02687659     History of Changes
Other Study ID Numbers: 2014-A00444-43
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016