NCT05523830

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

August 25, 2022

Last Update Submit

June 30, 2023

Conditions

Keywords

Energy expenditurePhysical ActivityWearables

Outcome Measures

Primary Outcomes (1)

  • Energy Expenditure Estimation Model

    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 Outcomes (3)

  • Heart rate (variability) algorithm

    1.5 years

  • Contribution of different bio signals to the estimation of energy expenditure

    1.5 years

  • Instantaneous energy expenditure

    1.5 years

Study Arms (1)

Healthy Subjects

56 healhty subjects will be recruited for the current study

Other: No Intervention

Interventions

No intervention

Healthy Subjects

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults that are able to be physically active

You may qualify if:

  • Aged between 18 and 64 years
  • Provided written informed consent
  • Able to be physically active assed with PAR-Q+

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples for deutrium dilution analysis to asses total body water

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Guy Plasqui

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 31, 2022

Study Start

May 18, 2022

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations