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临床试验/NCT05446454
NCT05446454已完成不适用

Criterion and Convergent Validity of Activity Monitors to Study Walking Activity

University of Rennes 21 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Detection rate of daily life walking bouts

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Detection rate of daily life walking bouts

时间窗: 8 days

Detection rate of daily life walking bouts by wearable activity monitors

Error level in the estimation of walking energy expenditure

时间窗: 1 day

Error level in the estimation of walking energy expenditure by wearable activity monitors

次要结局

未报告次要终点

研究者

发起方
University of Rennes 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexis LE FAUCHEUR

Associate professor

University of Rennes 2

研究点 (1)

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