MOTIONPODTM Validation in Free-living Conditio

NCT ID: NCT03235583

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-02
• Study Completion Date: 2013-10-11

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.

Conditions

Obese; Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MotionPod Validation

Medical device validation

Group Type: OTHER

MOTIONPODTM device validation

Intervention Type: DEVICE

MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method

Interventions

MOTIONPODTM device validation

MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

Pierre-Bénite, , France

Countries

France

Other Identifiers

2011.702

Identifier Type: -

Identifier Source: org_study_id