- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523830
Estimation of Energy Expenditure and Physical Activity Classification With Wearables (EEPAC)
Regular physical activity (PA) is proven to help prevent and treat several non-communicable diseases such as heart disease, stroke, and diabetes. Intensity is a key characteristic of PA that can be assessed by estimating energy expenditure (EE). However, the accuracy of the estimation of EE based on accelerometers are lacking. It has been suggested that the addition of physiological signals can improve the estimation. How much each signal can add to the explained variation and how they can improve the estimation is still unclear.
The goal of the current study is twofold:
to explore the contribution of heart rate (HR), breathing rate (BR) and skin temperature to the estimation of EE develop and validate a statistical model to estimate EE in simulated free-living conditions based on the relevant physiological signals.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physical activity (PA) is defined as any bodily movement produced by skeletal muscle that requires energy expenditure. The scientific evidence for the beneficial effects are irrefutable. Regular PA is proven to help prevent and treat several non-communicable diseases such as heart disease, stroke, diabetes and different forms of cancer.
PA is a complex behaviour that is characterized by frequency, intensity, time and type (FITT). In order to understand the effect of PA on health and our general well-being, it is essential to monitor all four characteristics of PA. A PA classification algorithm can assess the amount of time spent in different body postures and activity. Making it possible to assess frequency, time and type. In order to completely characterize PA, intensity needs to be estimated. This can be done by the estimation of energy expenditure (EE).
Wearables play a crucial role in the monitoring of PA. They are practical way to collect objective PA data in daily life, in an unobtrusive way, at a relatively low cost. Furthermore they can be applied as a motivational tool to increase PA. Accelerometry has been routinely used to quantify PA and to predict EE using linear and non-linear models. However, the relationship between EE and acceleration differs from one activity to another. For example, cycling can generate the same acceleration amplitude as running, but the EE may differ greatly. It is clear that acceleration alone has a limited accuracy to estimate EE from different activities.
Improving the estimation of EE could be achieved by first classifying the activity type. For each type of activity, different estimations can be used. There are numerous methods to classify PA and estimate EE. Literature describes the use of regression based equations combined with cut-points, linear models, non-linear models, decision trees, artificial neural networks, etc. It is still unclear what would be the best method to estimate EE, not to mention which features would contribute to the model.
Another possibility is to add a relevant bio-signal to the estimation model. Heart rate, breathing rate, temperature are all signals that have a response related to an increase in PA. Heart rate has been used previously to improve the EE estimation in combination with accelerometry. The breathing rate and temperature could contribute to the estimation of EE is still unclear.
Therefore, the goal of the current study is twofold. Firstly, to explore the contribution of different variables (physiological signals) to the estimation of EE and the classification of PA. Secondly, develop and validate a model to estimate EE and classify PA in simulated free-living conditions based on the relevant variables.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Wouter Bijnens
- Phone Number: +31 43 38 81455
- Email: wouter.bijnens@maastrichtuniversity.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged between 18 and 64 years
- Provided written informed consent
- Able to be physically active assed with PAR-Q+
Exclusion Criteria:
- A contraindication to physical activity
- A contraindication to wearing wearables, fixed by a hypoallergenic plaster
- Chronic disease
- A pace maker or any chest-implanted device
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Subjects
56 healhty subjects will be recruited for the current study
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy Expenditure Estimation Model
Time Frame: 1.5 years
|
The primary objective of this study is to develop and validate an energy expenditure estimation and physical activity classification algorithm based on wearable sensors.
To do so the relevant signals contributing to the classification of physical activity and the estimation of energy expenditure will be identified.
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate (variability) algorithm
Time Frame: 1.5 years
|
Design and validate a heart rate (variability) algorithm - Investigate the feasibility of modelling the instantaneous energy expenditure |
1.5 years
|
Contribution of different bio signals to the estimation of energy expenditure
Time Frame: 1.5 years
|
Assess the contribution of different bio signals to the estimation of energy expenditure
|
1.5 years
|
Instantaneous energy expenditure
Time Frame: 1.5 years
|
Investigate the feasibility of modelling the instantaneous energy expenditure
|
1.5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Guy Plasqui, Maastricht University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL80580.068.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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