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

NCT02687659 | Completed DMC

• 1 other identifier: 2014-A00444-43
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Sedentary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• total duration of recording in hours

  One week (sum of each day recording)

• number of subjects with adverse events

  one week

Study Arms (1)

Study group using TEMIS system

EXPERIMENTAL

using TEMIS system during physical exercises: walking, biking, running

Device: TEMIS system

Interventions

TEMIS system DEVICE

Wearing TEMIS system over the day during one week

Study group using TEMIS system

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• University Hospital, Toulouse: collaborator
• MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse: collaborator

Study Sites (1)

CHU Angers

Angers, Maine et Loire, 49933, France

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marc-Antoine CUSTAUD, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2014
• First Posted: February 22, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

FR (1)