Energy ExpenditureMOTIONPOD(TM)NCT01317732
MOTIONPOD (TM) Validation and Calibration Study
A study testing MOTIONPOD (TM) measures in people with Energy Expenditure, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure
- What is being tested?
- MOTIONPOD (TM) measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
Pierre-Bénite, 69495
About this study
Official title: Calibration and Validation of MOTIONPOD(TM) for Physical Activity Evaluation in Free-living Adults
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
- Conditions
- Energy Expenditure
- Being tested
- MOTIONPOD (TM) measures
- Keywords
- Energy expenditure, physical activity, accelerometer, magnetometer, monitoring
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| MOTIONPOD (TM) | Experimental | Not described Receives: Device: MOTIONPOD (TM) measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (3)
Identification and classification of the tasks performed during a 30-min free activity period
Measured: 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
Measured: 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.
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
Measured: During three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantal SIMON, Pr,PhD, MD, Principal investigator, Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317732
- Sponsor's protocol ID
- 2010.617
- Acronym
- MOTIONPOD(TM)
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2011
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25593289
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration and Validation of MOTIONPOD(TM) for Physical Activity Evaluation in Free-living Adults
- ClinicalTrials.gov ID
- NCT01317732
- Acronym / sponsor ID
- MOTIONPOD(TM) / 2010.617
- Conditions
- Energy Expenditure
- Keywords
- Energy expenditure, physical activity, accelerometer, magnetometer, monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOTIONPOD (TM) | Experimental | Device: MOTIONPOD (TM) measures |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOTIONPOD (TM) measuresIt 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 | Device | MOTIONPOD (TM) |
Primary outcome
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
3 secondary outcomes
Identification and classification of the tasks performed during a 30-min free activity period
Time frame: 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
Time frame: 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.
Time frame: During three hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 25593289Bastian 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.
Related trials for Energy Expenditure
Recruiting
Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism
Healthy Adult
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
Recruiting
Evaluation of Membrane Phospholipid and Energy Metabolism in Subjects at High Risk of Psychotic Transition
Patients With Ultra High Risk of Psychotic Transition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal SIMON, Pr,PhD, MD principal investigator
Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOTIONPOD (TM) measures in people with Energy Expenditure, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.