- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02687659
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
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maine et Loire
-
Angers, Maine et Loire, France, 49933
- Chu Angers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group using TEMIS system
using TEMIS system during physical exercises: walking, biking, running
|
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
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) |
One week (average of each day recording)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total duration of recording in hours
Time Frame: One week (sum of each day recording)
|
One week (sum of each day recording)
|
|
number of subjects with adverse events
Time Frame: one week
|
will be considered as adverse events
|
one week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc-Antoine CUSTAUD, MD, PhD, University Hospital, Angers
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-A00444-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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