Validity of Activity Monitors to Study Walking (VAMOS)

May 7, 2024 updated by: Alexis LE FAUCHEUR, University of Rennes 2

Criterion and Convergent Validity of Activity Monitors to Study Walking Activity

Wearable activity monitors represent a real opportunity to assess people' daily walking activity, however their level of validity remains poorly understood in the assessment of intermittent walking activity, i.e. as it occurs in everyday life conditions. Indeed, the available validation studies mainly focused on steps count accuracy of wearable activity monitors, but their validity to detect and quantify bouts of intermittent walking in daily life conditions remains insufficiently studied. It is important not only to determine which indicators would be the most accurate but also which methods would be the most suitable for detecting intermittent walking bouts, and then estimating energy expenditure. The main objective of the VAMOS project is to study the criterion and convergent validity of consumer-level and research-grade wearable activity monitors in assessing daily life intermittent walking in healthy subjects.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy participants aged between 20-80 years old will be studied.

Description

Inclusion Criteria:

  • Be at least 20 years old and under 80 years old.
  • Have understood the objectives of the study and its constraints.
  • Have read and signed a free and informed consent.
  • Be affiliated to the French social security system

Exclusion Criteria:

  • Known contraindications or limitations to walking, and reported by the participant.
  • Case of hypertension, heart failure, angina pectoris, diabetes, chronic obstructive pulmonary disease, proven by the presence of medication in relation to these diseases and the medical history reported by the participant.
  • Case of factors, medical treatments, or diseases likely to lead to a functional limitation to walking and/or a significant modification of the physiological responses to exercise, e.g. active smoking (ongoing or weaned for less than six months), cancer (ongoing), Parkinson's disease, kidney failure (ongoing), proven by the presence of medication in relation to these diseases and the medical history reported by the participant.
  • History of cardiovascular disease (heart failure, stroke, heart attack myocardium…) reported by the participant.
  • Woman with known ongoing pregnancy (self-declared) or breastfeeding woman.
  • Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
  • Simultaneous participation in another research involving the human person.
  • Consent withdrawal during the study.
  • Any health concern that would appear during the study and that no longer would allow the person to continue to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of daily life walking bouts
Time Frame: 8 days
Detection rate of daily life walking bouts by wearable activity monitors
8 days
Error level in the estimation of walking energy expenditure
Time Frame: 1 day
Error level in the estimation of walking energy expenditure by wearable activity monitors
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rennes 2

Collaborators

Ecole normale supérieure de Rennes (FRANCE)

Investigators

  • Principal Investigator: Alexis Le Faucheur, Ecole normale supérieure de Rennes (FRANCE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-A03382-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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