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Completed

NCT Number: NCT05936827

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Paavo Nurmi Center

Turku, 20540, Finland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ergometry

Diagnostic Test

Maximal exercise test is performed on a cycle ergometer (Ergoline 800 s; VIASYS Healthcare, Germany). The test begins at a workload of 50 W, which is increased by 25 W (males) every 1 min or the test begins with 25 W which is increased by 25 W (females) every 1 min until exhaustion.

The mean workload during the last 4 min of work is calculated and the VO2max is estimated according to the American College of Sports Medicine (American College of Sports Medicine.

ACSM's guidelines for exercise testing and prescription. Sixth edition. Baltimore: Williams & Wilkins 2000:304). Blood lactate concentration is measured immediately and 1 min after exhaustion from capillary samples (Biosen C-Line Glucose and Lactate analyzer, EKFdiagnostic GmbH, Germany). (Pahkala et al. 2013.)

Ergospirometry

Diagnostic Test

VO2max is measured using a stationary bicycle ergometer (Ergoline 800 s; VIASYS Healthcare, Germany. For males, the test starts with 100 W which is increased by 25 W every 1 min until volitional exhaustion. For females, the test starts with 50 W which is increased by 25 W every 1 min until volitional exhaustion.

Ventilation and gas exchange (Vyntus CPX, Vyaire Medical Gmbh, Leibnizstrasse, Hoechberg, Germany) are measured during the test. Subject's blood lactate concentration is measured from capillary samples immediately and 1 min after exhaustion (Biosen C-Line Glucose and Lactate analyzer, EKF-diagnostic GmbH, Germany). The heart rate of the participants is followed continuously (CardioSoft GE, CardioSoft V6.51; GE Medical Systems Information Technologies, USA). (Heiskanen et al. 2021.)

Primary outcomes

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

    Time frame: 4 minutes

  2. Gyrocardiography measurement

    Time frame: 1 minute

    Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.

  3. Gyrocardiography measurement

    Time frame: 3 minutes

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

Secondary outcomes

  1. Heart rate per minute and Heart rate variability

    Time frame: 1 minute

    Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.

  2. Heart rate per minute and Heart rate variability

    Time frame: 3 minutes

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

  3. Systolic and diastolic phase (blood pressure RR)

    Time frame: 1 minute

    Will be performed at least once at rest before the (spiro)ergometry.

  4. Respiration rate per minute

    Time frame: 1 minute

    Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.

  5. Respiration rate per minute

    Time frame: 3 minutes

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

  6. Cardiac Strength profile

    Time frame: 1 minute

    Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.

  7. Cardiac Strength profile

    Time frame: 3 minutes

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

Sponsors and collaborators

Lead sponsor

Precordior Ltd

Industry

Collaborators

  • Paavo Nurmi Centre

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2023
Registry last updated
Jul 14, 2025

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.

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