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

NCT05936827 | Completed

• 1 other identifier: Sport Study
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  4 minutes

• Gyrocardiography measurement

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

  1 minute

• Gyrocardiography measurement

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

  3 minutes

Secondary Outcomes (7)

• Heart rate per minute and Heart rate variability

  1 minute

• Heart rate per minute and Heart rate variability

  3 minutes

• Systolic and diastolic phase (blood pressure RR)

  1 minute

• Respiration rate per minute

  1 minute

• Respiration rate per minute

  3 minutes

Study Arms (2)

athletic group

Moderate to high PA levels according to IPAQ.

Diagnostic Test: Ergospirometry

non-athletic group

Low levels of PA according to IPAQ.

Diagnostic Test: Ergometry

Interventions

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.)

non-athletic group

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.)

athletic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects from the area of Turku. Half of the subjects (n=100) are allocated to athletic group (moderate to high Physical activity, PA, levels according to International Physical Activity Questionnaire, IPAQ) and other half (n=100) to non-athletic group (low levels of PA according to IPAQ).

You may qualify if:

• 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

You may not qualify if:

• Declined to participate
• Resting RR before the ergometry \> 180/110mmHg

Sponsors & Collaborators

• Precordior Ltd: lead
• Paavo Nurmi Centre: collaborator

Study Sites (1)

Paavo Nurmi Center

Turku, 20540, Finland

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Olli Heinonen, PhD

  Paavo Nurmi Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 10, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

FI (1)