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MOTIONPODTM Validation in Free-living Conditio

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Healthy Volunteers
Obese

Treatments

Device: MOTIONPODTM device validation

Study type

Interventional

Funder types

Other

Identifiers

NCT03235583
2011.702

Details and patient eligibility

About

In this study, the investigators propose to assess the validity in measuring physical activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm and an activity-specific multilinear prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns will be compared to those of two existing activity or movement monitors: the triaxial accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the cost of a calibration of the heart-rate/EE relationship that limits its use in large population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years of both gender and with broad range of body mass index and physical activity level. The subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total of 14 days in everyday life conditions and complete a physical activity diary. In half of the subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW. The other 60 subjects will be studied twice, one month apart, to test the reproducibility of the measures.

Enrollment

128 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male and female subjects
  • Age : 18 to 75 years
  • Patients or healthy volunteers
  • 40 obese subjects (BMI ≥ 30 kg/m2), 40 non-obese (BMI <30 kg/m2) and active (PA level evaluated by the RPAQ questionnaire) subjects, 40 non-obese and sedentary subjects
  • Absence of cardiac rate disorders

Exclusion criteria

  • Subjects with acute disorders: cardiovascular or neoplastic, severe infection during 3 previous months
  • Subjects with a pathology restricting the walking distance (confinement, distance <200 meters)
  • Subjects with implants (Pacemaker, cardiac implant or another active implant)
  • Claustrophobic subjects (for subjects participating to "doubly labelled water" protocol)
  • Drug use that could affect energy expenditure

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

128 participants in 1 patient group

MotionPod Validation
Other group
Description:
Medical device validation
Treatment:
Device: MOTIONPODTM device validation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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