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Clinical Trials/NCT05446454
NCT05446454
Completed
Not Applicable

Criterion and Convergent Validity of Activity Monitors to Study Walking Activity

University of Rennes 21 site in 1 country60 target enrollmentSeptember 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Validity Study of Activity Monitors in Healthy Subjects
Sponsor
University of Rennes 2
Enrollment
60
Locations
1
Primary Endpoint
Detection rate of daily life walking bouts
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2022
End Date
October 16, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Rennes 2
Responsible Party
Principal Investigator
Principal Investigator

Alexis LE FAUCHEUR

Associate professor

University of Rennes 2

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Detection rate of daily life walking bouts

Time Frame: 8 days

Detection rate of daily life walking bouts by wearable activity monitors

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

Study Sites (1)

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