Clinical trial NCT03235583: MOTIONPODTM Validation in Free-living Conditio
Official title: Validation of MotionPODTM a Device for Measuring Physical Activity, in Free-living Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Healthy Volunteers
Keywords: Energy expenditure
physical activity
accelerometer
magnetometer
monitoring
free-living conditions
doubly labelled water
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction
timeFrame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
measure: Daily physical activity energy expenditure (PAEE) using DLW (gold standard measure) (modality A)
timeFrame: PAEE measurement will be measured over the 14-day study-period (Modality A)
measure: Daily physical activity energy expenditure (PAEE) Actiheart TM estimates (modalities A & B)
timeFrame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
measure: Daily physical activity energy expenditure (PAEE) ActigraphGT3X+ TM estimates (modalities A & B)
timeFrame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
Secondary outcomes:
measure: Identification and classification of activity/posture patterns by the MOTIONPODTM device (assessed by confusion matrices)
timeFrame: PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)
measure: Identification and classification of activities/postures patterns collected in the activity diary
timeFrame: PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)
measure: (BMI < or > 30 kg/m2).
timeFrame: Baseline (at inclusion)
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud
Study officials:
References: