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OpenTrials
Completed

NCT Number: NCT05446454

Validity of Activity Monitors to Study Walking

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health, Sport and Movement Laboratory (M2S)

Bruz, 35170, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Detection rate of daily life walking bouts

    Time frame: 8 days

    Detection rate of daily life walking bouts by wearable activity monitors

  2. 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

Sponsors and collaborators

Lead sponsor

University of Rennes 2

Other

Collaborators

  • Ecole normale supérieure de Rennes (FRANCE)

Registry information

Official study title

Criterion and Convergent Validity of Activity Monitors to Study Walking Activity

Acronym: VAMOS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.