TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- University Hospital, Angers
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- concordance (kappa score) between actual and estimated physical activity
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Detailed Description
Healthy subjects have to make different physical activities, wearing the TEMIS system like slow and fast walking, biking, running.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
- total duration of recording in hours(One week (sum of each day recording))
- number of subjects with adverse events(one week)