HealthyNCT05936827
Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness
An observational study of Healthy, run by Precordior Ltd at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ergometry and Ergospirometry
- How many people
- 102 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria
- Declined to participate
- Resting RR before the ergometry > 180/110mmHg
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Ergometry, Ergospirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgometryDiagnostic 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.)
ErgospirometryDiagnostic 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.)
| Study group | Role | What they receive |
|---|---|---|
| athletic group | Moderate to high PA levels according to IPAQ. Receives: Diagnostic Test: Ergospirometry | |
| non-athletic group | Low levels of PA according to IPAQ. Receives: Diagnostic Test: Ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise.
Measured: 4 minutes
Gyrocardiography measurement
Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.
Measured: 1 minute
Gyrocardiography measurement
Lasts 1 minute and is performed 3 minutes after the (spiro)ergometry.
Measured: 3 minutes
Secondary outcomes (7)
Heart rate per minute and Heart rate variability
Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.
Measured: 1 minute
Heart rate per minute and Heart rate variability
Lasts 1 minute and is performed 3 minutes after the (spiro)ergometry.
Measured: 3 minutes
Systolic and diastolic phase (blood pressure RR)
Will be performed at least once at rest before the (spiro)ergometry.
Measured: 1 minute
Respiration rate per minute
Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.
Measured: 1 minute
Respiration rate per minute
Lasts 1 minute and is performed 3 minutes after the (spiro)ergometry.
Measured: 3 minutes
Cardiac Strength profile
Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.
Measured: 1 minute
Cardiac Strength profile
Lasts 1 minute and is performed 3 minutes after the (spiro)ergometry.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precordior Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paavo Nurmi Centre
- Responsible party
- Sponsor
- Investigators
- Olli Heinonen, PhD, Principal investigator, Paavo Nurmi Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936827
- Sponsor's protocol ID
- Sport Study
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness
- ClinicalTrials.gov ID
- NCT05936827
- Acronym / sponsor ID
- Sport Study
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Precordior LtdIndustry (pharma, biotech, devices)
- Collaborators
- Paavo Nurmi Centre
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| athletic group | – | Diagnostic Test: ErgospirometryModerate to high PA levels according to IPAQ. |
| non-athletic group | – | Diagnostic Test: ErgometryLow levels of PA according to IPAQ. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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
- Belong to non-athletic group
Key exclusion criteria (3 listed)
- Not meeting inclusion criteria
- Declined to participate
- Resting RR before the ergometry > 180/110mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgometryMaximal 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 | non-athletic group |
| ErgospirometryVO2max 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.) | Diagnostic test | athletic group |
Primary outcome
The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise.
Time frame: 4 minutes
Gyrocardiography measurement
Time frame: 1 minute
Lasts 1 minute and is performed at least once at rest before the (spiro)ergometry.
Gyrocardiography measurement
Time frame: 3 minutes
Lasts 1 minute and is performed 3 minutes after the (spiro)ergometry.
7 secondary outcomes
Heart rate per minute and Heart rate variability
Time frame: 1 minute
Heart rate per minute and Heart rate variability
Time frame: 3 minutes
Systolic and diastolic phase (blood pressure RR)
Time frame: 1 minute
Respiration rate per minute
Time frame: 1 minute
Respiration rate per minute
Time frame: 3 minutes
Cardiac Strength profile
Time frame: 1 minute
Cardiac Strength profile
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olli Heinonen, PhD principal investigator
Paavo Nurmi Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Precordior Ltd at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise. (time frame: 4 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.