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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01317732
First received: March 16, 2011
Last updated: March 4, 2014
Last verified: March 2014
  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

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


Enrollment: 128
Study Start Date: October 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MOTIONPOD (TM) measures
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
Pierre Bénite, France, 69495
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: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01317732     History of Changes
Other Study ID Numbers: 2010.617
Study First Received: March 16, 2011
Last Updated: March 4, 2014
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 October 22, 2014