MOTIONPOD (TM) Validation and Calibration Study - Full Text View

Purpose

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

Condition	Intervention
Energy Expenditure	Device: MOTIONPOD (TM) measures

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Calibration and Validation of MOTIONPOD(TM) for Physical Activity Evaluation in Free-living Adults

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

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 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification and classification of the tasks performed during a 30-min free activity period [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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 [ Time Frame: During three hours ] [ Designated as safety issue: No ]
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. [ Time Frame: During three hours ] [ Designated as safety issue: No ]
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 in comparison with 1) indirect calorimetry, 2) existing commercially activity monitors

Estimated Enrollment:	60
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317732

Contacts

Contact: Chantal Simon, Pr.PhD, MD

4 78 86 29 81 ext +33

chantal.simon@univ-lyon1.fr

Locations

France
Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)	Recruiting
Pierre Bénite, France, 69495
Contact: Stéphanie LAMBERT-PORCHERON, MD 4 78 86 19 72 ext +33 stephanie.lambert-porcheron@chu-lyon.fr
Contact: Nathalie FEUGIER, MD 4 78 86 19 72 ext +33 nathalie.feugier@chu-lyon.fr
Principal Investigator: Chantal SIMON, Pr,PhD,MD
Sub-Investigator: Stéphanie LAMBERT-PORCHERON, MD
Sub-Investigator: Nathalie FEUGIER, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Chantal SIMON, Pr,PhD, MD

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

More Information

No publications provided

Responsible Party:	Chantal Simon, PhD, MD, Hospices Civils de Lyon- Centre de recherche en Nutrition Humaine-Rhône-Alpes
ClinicalTrials.gov Identifier:	NCT01317732 History of Changes
Other Study ID Numbers:	2010.617
Study First Received:	March 16, 2011
Last Updated:	March 16, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:

Energy expenditure, physical activity, accelerometer, magnetometer, monitoring

ClinicalTrials.gov processed this record on May 19, 2013

MOTIONPOD (TM) Validation and Calibration Study (MOTIONPOD(TM))