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Clinical Trials/NCT05936827
NCT05936827CompletedNot Applicable

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

Precordior Ltd1 site in 1 country102 target enrollmentStarted: March 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
102
Locations
1
Primary Endpoint
The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 4 minutes

Gyrocardiography measurement

Time Frame: 3 minutes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Precordior Ltd
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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