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临床试验/NCT06132724
NCT06132724已完成不适用

Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices à la frontière de l'Exercice modéré

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月5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
20
试验地点
1
主要终点
Database of physiological signals

研究概览

简要总结

The goal of this observational study is to learn about physiological transitions around the limit of moderate exercise intensity on cardiac, respiratory and motor modalities, in healthy population.

The main questions it aims to answer is:

  • is it possible to define criteria on cardiac, respiratory and motor modalities to identify transitions?
  • are those transitions visible on embedded and non-intrusive monitoring equipment?
  • are those identified transitions somehow connected to first ventilatory threshold (VT1)?

Participants will do a sub-maximal effort test on cycloergometer calibrated to make them cross their first ventilatory threshold.

详细描述

Cycling is a commonly prescribed activity when it comes to physical activities for rehabilitation. Because it is soft and progressive effort, cycling suits well for patients with chronic conditions (diabete, cancer, fibromyalgia, ...) For safety and effectiveness of the activity, it is necessary to prescribe activity at a regular and moderate intensity. This can be achieved by personalizing intensities to match specifically the patient health condition in order to build an efficient and progressive rehabilitation program.

Physical activity prescription rely on four pillars: frequency, duration, volume and intensity. While first three pillars are quite easy to regulate,effort intensity is harder to handle on training planning. It is harder to measure, and defining personalized guideline for practice is more complex.

It is known that first ventilatory threshold (VT1) is a individualized marker representing the higher limit of moderate intensity effort zone. It makes it an interesting tool for the prescription of intensity for retraining purposes: it guaranties a safe practice, intense enough to make beneficial physiological adaptations for the patient.

In this retraining context and with this study, we aim to identify markers of this transition on cardiac, respiratory and motor modalities, with embedded and non intrusive equipment, during a sub-maximal effort test in laboratory.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Capability to cycle during 20min
  • No contraindication to cycling at a moderate pace
  • No acute pathology (less than 2 years old)
  • No cardiac or respiratory chronic pathology
  • No locomotive problem on the spine or the lower limbs
  • No recent injuries (less than 2 months)
  • Stature compatible with the use of the plethysmography t-shirt

排除标准

  • Pregnant (urine strip test) or breastfeeding women
  • Persons referred to in articles L1121-5 to L1121-8 of the CSP (protected persons) person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
  • Subject being excluded from another study
  • Subject who reached the ceiling of 4500 euros due to their participation in other studies involving human in the past 12 months

结局指标

主要结局

Database of physiological signals

时间窗: 20 minutes

Synchronized signals from embedded and non-intrusive connected devices for cardiorespiratory and motricity measurements and equivalent laboratory measurements during cycling on a cyclo-ergometer

次要结局

  • Evaluation of the feeling of wearing equipment(15 minutes)
  • Criteria for the observation of a cardiac transition(6 months)
  • Criteria for the observation of a respiratory transition(6 months)
  • Criteria for the observation of a motricity transition(6 months)
  • Multi-modal prediction of the first ventilatory threshold(6 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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