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临床试验/NCT05936827
NCT05936827已完成不适用

Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness

Precordior Ltd1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年3月1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
102
试验地点
1
主要终点
The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise.

研究概览

简要总结

The goal of this study is to produce a solution to measure the cardiorespiratory fitness (CRF), which can be used by commercially available smartphones without extra equipment, add-ons and special know-how.

This observational study with follow-up is to test the feasibility of a new non-invasive cardiac measurement method (gyrocardiography, GCG) in detecting hemodynamic parameters to measure exercise capacity and cardiorespiratory fitness in healthy subjects.

The objective is to produce a solution which can be used to measure the exercise capacity and cardiorespiratory fitness (CRF) of the exercisers, keep-fit athletes and professional athletes using hemodynamic parameters such as:

  • Heart rate and Heart rate variability
  • Cardiac Strength profile
  • Systolic and diastolic phase
  • Breathing frequency
  • VO2max

Participants are either athletes or non-athletic persons. The athletes will perform spiroergometry and non-athletic persons ergometry to measure the CRF expressed as VO2max.

Following parameters will be measured during the (spiro)ergometry:

  • Maximum workload (W)
  • VO2max (ml/kg/min)
  • HRmax
  • Blood lactate
  • Respiratory exchange ratio RER (VO2/VCO2)

The GCG measurements for acquiring the hemodynamic parameters are performed before and after the (spiro)ergometry using smartphone. During a 1- minute GCG measurement, the smart phone is placed on the chest in the middle of the sternum.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-65 years
  • No diagnosed cardiovascular diseases (mild hypertension or hypercholesterolemia are still allowed)
  • No medication affecting heart rate (i.e. Beta blocker)
  • Signed informed consent
  • Follow-up visit:
  • Belong to non-athletic group
  • Intention to change physical activity habits
  • Willing to participate to the follow-up visit

排除标准

  • Not meeting inclusion criteria
  • Declined to participate
  • Resting RR before the ergometry > 180/110mmHg

结局指标

主要结局

The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise.

时间窗: 4 minutes

Gyrocardiography measurement

时间窗: 3 minutes

Lasts 1 minute and is performed 3 minutes after the (spiro)ergometry.

次要结局

  • Systolic and diastolic phase (blood pressure RR)(1 minute)
  • Respiration rate per minute(3 minutes)
  • Heart rate per minute and Heart rate variability(3 minutes)
  • Cardiac Strength profile(3 minutes)

研究者

发起方
Precordior Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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