Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-17 @ 9:42 PM
Study NCT ID:
NCT02687659
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2014-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2014-05-31', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concordance (kappa score) between actual and estimated physical activity', 'timeFrame': 'One week (average of each day recording)', 'description': '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:\n\nlying position, sitting position, standing position, walking activity, running activity, bicycle activity, use of a vehicle (car, bus)'}], 'secondaryOutcomes': [{'measure': 'total duration of recording in hours', 'timeFrame': 'One week (sum of each day recording)'}, {'measure': 'number of subjects with adverse events', 'timeFrame': 'one week', 'description': 'will be considered as adverse events\n\n* allergia\n* discomfort with removal of the system'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy', 'Sedentary']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': 'Healthy subjects have to make different physical activities, wearing the TEMIS system like slow and fast walking, biking, running.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women 18 - 50 yo\n* BMI between 18 and 30\n* Without chronic disease or chronic treatment (oral contraception is allowed)\n* Normal electrocardiogram\n* Able to do all the specified physical activity requested by the protocol\n* Able to use smart phone and computers\n* With access to WIFI, bicycle, and car\n* Living in the close area\n* Affiliated to public health insurance\n\nExclusion Criteria:\n\n* Severe allergia\n* Severe skin lesions at the thorax level\n* Not able to use correctly the TEMIS system\n* Will take plane during the week of evaluation\n* Under protection'}, 'identificationModule': {'nctId': 'NCT02687659', 'acronym': 'TEMIS', 'briefTitle': 'TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity', 'orgStudyIdInfo': {'id': '2014-A00444-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group using TEMIS system', 'description': 'using TEMIS system during physical exercises: walking, biking, running', 'interventionNames': ['Device: TEMIS system']}], 'interventions': [{'name': 'TEMIS system', 'type': 'DEVICE', 'description': 'Wearing TEMIS system over the day during one week', 'armGroupLabels': ['Study group using TEMIS system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'state': 'Maine et Loire', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Marc-Antoine CUSTAUD, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, {'name': 'MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}