NCT05936827

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Precordior Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ergometry	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.)
DIAGNOSTIC_TEST	Ergospirometry	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.)

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-10
• Last updated: 2025-07-14

Locations

1 site across 1 country: Finland