HealthyTEMISNCT02687659
TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
A study testing TEMIS system in people with Healthy and Sedentary, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- TEMIS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- With access to WIFI, bicycle, and car
- Living in the close area
- Affiliated to public health insurance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Healthy subjects have to make different physical activities, wearing the TEMIS system like slow and fast walking, biking, running.
- Being tested
- TEMIS system
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEMIS systemDevice
Wearing TEMIS system over the day during one week
| Study group | Role | What they receive |
|---|---|---|
| Study group using TEMIS system | Experimental | using TEMIS system during physical exercises: walking, biking, running Receives: Device: TEMIS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One week (average of each day recording)
Secondary outcomes (2)
total duration of recording in hours
Measured: One week (sum of each day recording)
number of subjects with adverse events
will be considered as adverse events
- allergia
- discomfort with removal of the system
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- University Hospital, Toulouse, MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
- Responsible party
- Sponsor
- Investigators
- Marc-Antoine CUSTAUD, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687659
- Sponsor's protocol ID
- 2014-A00444-43
- Acronym
- TEMIS
- Status last verified
- Feb 2016
- First submitted
- 31 May 2014
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
- ClinicalTrials.gov ID
- NCT02687659
- Acronym / sponsor ID
- TEMIS / 2014-A00444-43
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- University Hospital, Toulouse, MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group using TEMIS system | Experimental | Device: TEMIS systemusing TEMIS system during physical exercises: walking, biking, running |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEMIS systemWearing TEMIS system over the day during one week | Device | Study group using TEMIS system |
Primary outcome
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)
2 secondary outcomes
total duration of recording in hours
Time frame: One week (sum of each day recording)
number of subjects with adverse events
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-Antoine CUSTAUD, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEMIS system in people with Healthy and Sedentary, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance (kappa score) between actual and estimated physical activity (time frame: One week (average of each day recording)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.