Clinical trial NCT05936827: Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness
Official title: Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Precordior Ltd
Sponsor class: INDUSTRY
Collaborators: name: Paavo Nurmi Centre
First posted: 2023-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: The maximum (max) rate (V) of oxygen (O₂) your body is able to use during exercise.
timeFrame: 4 minutes
measure: Gyrocardiography measurement
timeFrame: 1 minute
measure: Gyrocardiography measurement
timeFrame: 3 minutes
Secondary outcomes:
measure: Heart rate per minute and Heart rate variability
timeFrame: 1 minute
measure: Heart rate per minute and Heart rate variability
timeFrame: 3 minutes
measure: Systolic and diastolic phase (blood pressure RR)
timeFrame: 1 minute
measure: Respiration rate per minute
timeFrame: 1 minute
measure: Respiration rate per minute
timeFrame: 3 minutes
measure: Cardiac Strength profile
timeFrame: 1 minute
measure: Cardiac Strength profile
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Paavo Nurmi Center
Study officials:
affiliation: Paavo Nurmi Center
name: Olli Heinonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: