MOTIONPODTM Validation in Free-living Conditio

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235583
• Other study ID #: 2011.702
• Status: Completed
• Phase: N/A
• First received: July 28, 2017
• Last updated: August 3, 2017
• Start date: April 2, 2012
• Est. completion date: October 11, 2013

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 11, 2013
• Est. primary completion date: October 11, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Obese

Intervention

Device:
• MOTIONPODTM device validation
MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	(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)