MOTIONPODTM Validation in Free-living Conditio

Validation of MotionPODTM a Device for Measuring Physical Activity, in Free-living Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Obese
• Intervention / Treatment: Device: MOTIONPODTM device validation

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MotionPod Validation; Medical device validation	Device: MOTIONPODTM device validation; MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction	MotionPodTM predictions will be calculated with the newly developed algorithms to evaluate the concordance between the physical activity energy expenditure (PAEE) estimated by the MOTIONPODTM and that of 2 physical activity monitors: the Actigraph GT3X+TM and the ActiheartTM. The estimation of PAEE by MotionPodTM will be compared with the measure of PAEE by DLW (gold standard measure, primary outcome 2/), with the measure of PAEE by Actiheart TM (primary outcome 3/), and with the measure of PAEE by ActigraphGT3X+ TM (primary outcome 4/).	PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
Daily physical activity energy expenditure (PAEE) using DLW (gold standard measure) (modality A)	Daily Total Energy Expenditure (TEE) and PAEE standards will be measured with the DLW reference method. Briefly Resting metabolic Rate (RMR) will be measured via indirect calorimetry using a ventilated open-hood metabolic cart after a 12h-overnight fast. TEE will be determined using a 14-day multipoint DLW protocol. After providing a baseline urine sample, subjects will ingest a premixed dose of H218O (10% enriched) and 2H2O (99.85% enriched) DLW. Equilibration will be assessed in urine samples collected at 4h and 5h post dose. Subsequent urine samples will be collected every two days of the 14 days of the protocol. 2H2 and 18O isotopic enrichment will be analyzed in quadruplicate by pyrolysis on an elemental analyzer (Flash HT; ThermoFisher) interfaced with an IRMS (Delta V, ThermoFisher).	PAEE measurement will be measured over the 14-day study-period (Modality A)
Daily physical activity energy expenditure (PAEE) Actiheart TM estimates (modalities A & B)	ActiheartTM PAEE predictions will be calculated using the Actiheart software.	PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
Daily physical activity energy expenditure (PAEE) ActigraphGT3X+ TM estimates (modalities A & B)	ActigraphGT3X+TM PAEE predictions will be calculated using the ActigraphGT3X+ TM software.	PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification and classification of activity/posture patterns by the MOTIONPODTM device (assessed by confusion matrices)	Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary. The recognition rate of activity typologies (lying, sitting, inactive standing, active standing, walking, biking) by the MOTIONPODTM will be compared to data of the physical activity diary (measures (secondary measure outcome 2/). Confusion matrices will be used to compare the diary measures (secondary measure outcome 2/) with the MOTIONPODTM outputs.	PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)
Identification and classification of activities/postures patterns collected in the activity diary	Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary.	PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)
(BMI < or > 30 kg/m2).	to evaluate de concordance of MOTIONPODTM predictions with standard measure according to activity level, as previously described by subgroups	Baseline (at inclusion)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2012
• Primary Completion (Actual): October 11, 2013
• Study Completion (Actual): October 11, 2013

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Energy expenditure; physical activity; accelerometer; monitoring; doubly labelled water; magnetometer; free-living conditions
• Other Study ID Numbers: 2011.702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No