NCT01317732

Brief Summary

In this study we propose 1) to develop a new multisensor monitoring system associating a tri-axial accelerometer and a magnetometer to measure physical activity in free-living adults, 2) to perform its calibration and assess its validity in a series of activity tasks in comparison with the measure of energy expenditure by indirect calorimetry as the criterion measure, and with existing physical activity monitors (cardiofrequencemetry and accelerometers used either alone or in combination). Briefly the subjects will perform a series of standardized activity tasks of different intensities and a 30-min free physical activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors. Physical activity energy expenditure will be measured using a metabolic gas analyser. Data of the 30 first subjects will be used to develop new algorithms to identify the different activity tasks and to estimate the related energy expenditures. Data of the following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry and existing physical activity monitors

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 28, 2019

Status Verified

March 1, 2014

Enrollment Period

3 years

First QC Date

March 16, 2011

Last Update Submit

May 23, 2019

Conditions

Energy Expenditure

Keywords

Energy expenditure, physical activity, accelerometer, magnetometer, monitoring

Outcome Measures

Primary Outcomes (1)

  • Estimation by the MOTIONPODTM of the physical activity energy expenditure (PAEE) during a 30-min free activity period in comparison with the measure of PAEE by indirect calorimetry

    30 minutes

Secondary Outcomes (3)

  • Identification and classification of the tasks performed during a 30-min free activity period

    30 minutes

  • Estimation by the MOTIONPODTM of the physical activity energy expenditure during each of the tasks performed during the experiment in comparison with 1) indirect calorimetry, 2) existing commercially activity monitors

    During three hours

  • Intensity classification by the MOTIONPODTM of the physical activity energy expenditure during each of the tasks performed during the experiment and during the 30-min free activity period.

    During three hours

Study Arms (1)

MOTIONPOD (TM)

EXPERIMENTAL
Device: MOTIONPOD (TM) measures

Interventions

MOTIONPOD (TM) measuresDEVICE

It is a study with a single arm. The MOTIONPOD TM measures are compared with simultaneous estimations obtained with the criteria measure (indirect calorimeter) and with existing activity monitors (heart rate monitor POLAR; different accelerometers - rT3 et Actigraph GT3X-, Actiheart, Sensewear Pro2 Armband) After physical fitness evaluation, different activity monitors are set up and the subjects perform a series of standardised activity tasks of different intensities, and well as a 30-min free activity period. Physical activity energy expenditure is measured at the end of each task using a metabolic gas analyser

MOTIONPOD (TM)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal-weight, overweight or obesity according to body mass index
  • Low,moderate or high level of physical activity as estimated by questionnaire
  • No angina and/or peripheral arterial disease symptoms or medical history

You may not qualify if:

  • Subjects with cardiac implants
  • Claustrophobic subjects
  • Drug use that could affect energy expenditure
  • Medical history or evolving disease which are a contra-indication for moderate physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)

Pierre-Bénite, 69495, France

Location

Related Publications (1)

  • Bastian T, Maire A, Dugas J, Ataya A, Villars C, Gris F, Perrin E, Caritu Y, Doron M, Blanc S, Jallon P, Simon C. Automatic identification of physical activity types and sedentary behaviors from triaxial accelerometer: laboratory-based calibrations are not enough. J Appl Physiol (1985). 2015 Mar 15;118(6):716-22. doi: 10.1152/japplphysiol.01189.2013. Epub 2015 Jan 15.

    PMID: 25593289RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Chantal SIMON, Pr,PhD, MD

    Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 28, 2019

Record last verified: 2014-03

Locations

FR(1)