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Heart Rate VariabilityNCT06549192

Autonomic Responses of Amateur Child Athletes to Aerobic Exercise Test

A study testing 20 meter shuttle run test in people with Heart Rate Variability and Sport, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study was to investigate the relationship between aerobic capacity, which will be revealed by aerobic exercise test, and HRV, blood pressure, heart rate and pulmonary function parameters in healthy children interested in different sports branches (boxing, weightlifting, taekwando, swimming). Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Heart Rate Variability, Sport
What is being tested?
20 meter shuttle run test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Sep 2024to 1 Jul 2025
Phase
Interventional
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 6 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 6-18 years old, registered to a club in boxing, weightlifting, taekwando and swimming (4 groups), children and adolescents who have been actively participating in their training for at least 3 months

Who cannot join

  • People with neurological, orthopedic, cardiovascular diseases, those with any acute or chronic illness, smokers or drug users, elite level athletes

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sivas Cumhuriyet University

    Sivas, Sivas, 58140

Other trials in Turkey (Türkiye)

About this study

The aim of our study was to investigate the relationship between aerobic capacity, which will be revealed by aerobic exercise test, and HRV, blood pressure, heart rate and pulmonary function parameters in healthy children interested in different sports branches (boxing, weightlifting, taekwando, swimming). The main questions it aims to answer are:

  • Is there any relationship between aerobic capacity demonstrated by 20 m shuttle test and heart rate variability, blood pressure, heart rate and respiratory parameters in different sports branches?
  • Is there a relationship between the month/year that children/adolescents are involved in sports and HRV, blood pressure and respiratory parameters?
Read more

Participants:

  • Before the exercise test, ECG, blood pressure, heart rate and pulmonary function test will be performed.
  • A 20 meter shuttle run test will be performed.
  • Measurements will be repeated after the exercise test.
Being tested
20 meter shuttle run test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20 meter shuttle run testOther

    20 Meter Shuttle Run Test: Subjects run distance of 20 meters round trip. Running speed is monitored at certain intervals with help of a tape recorder that gives a signal. Subjects start running when they hear first beep and must reach other line(one foot must cross the line) by second beep. When they hear second signal, they return to starting line. The speed, which is slow at beginning, gradually increases every 10 seconds. The subject adjusts his/her pace so that he/she is on the other line at the second signal. If subject misses one signal and catches second signal, test continues. If subject misses two signals in row and doesn't reach line at other signal, test is terminated. At end of test, aerobic power values are calculated from VO2max estimation table in ml/kg/min according to number of sit-ups run. At end of test, marks obtained by athlete are calculated and VO2max value of subject is calculated in ml/kg/min from evaluation table.

Study groups in NCT06549192
Study groupRoleWhat they receive
Group 1: BoxersActive comparatorBefore the assessment begins, the children will be asked whether they have consumed any beverages containing theine and caffeine, such as tea, coffee, cola and energy drinks, which can affect the heart, in the last two hours. If this is the case, the shooting will be postponed to the next day without consuming such beverages. Participants will first have their information recorded on the general evaluation form. Their resting heart rate variability, blood pressure, heart rate and respiratory function will then be measured. After these initial measurements at rest, the participants will be given a 20 meter shuttle run test. At the end of the test, the participant will be taken to the first assessment room for a second assessment. Here, ECG, blood pressure and heart rate, spirometer measurements will be repeated. All outcome measurements will be recorded on the evaluation form.
Receives: Other: 20 meter shuttle run test
Group 2: WeightliftersActive comparatorBefore the assessment begins, the children will be asked whether they have consumed any beverages containing theine and caffeine, such as tea, coffee, cola and energy drinks, which can affect the heart, in the last two hours. If this is the case, the shooting will be postponed to the next day without consuming such beverages. Participants will first have their information recorded on the general evaluation form. Their resting heart rate variability, blood pressure, heart rate and respiratory function will then be measured. After these initial measurements at rest, the participants will be given a 20 meter shuttle run test. At the end of the test, the participant will be taken to the first assessment room for a second assessment. Here, ECG, blood pressure and heart rate, spirometer measurements will be repeated. All outcome measurements will be recorded on the evaluation form.
Receives: Other: 20 meter shuttle run test
Group 3: Taekwondo playersActive comparatorBefore the assessment begins, the children will be asked whether they have consumed any beverages containing theine and caffeine, such as tea, coffee, cola and energy drinks, which can affect the heart, in the last two hours. If this is the case, the shooting will be postponed to the next day without consuming such beverages. Participants will first have their information recorded on the general evaluation form. Their resting heart rate variability, blood pressure, heart rate and respiratory function will then be measured. After these initial measurements at rest, the participants will be given a 20 meter shuttle run test. At the end of the test, the participant will be taken to the first assessment room for a second assessment. Here, ECG, blood pressure and heart rate, spirometer measurements will be repeated. All outcome measurements will be recorded on the evaluation form.
Receives: Other: 20 meter shuttle run test
Group 4: SwimmerActive comparatorBefore the assessment begins, the children will be asked whether they have consumed any beverages containing theine and caffeine, such as tea, coffee, cola and energy drinks, which can affect the heart, in the last two hours. If this is the case, the shooting will be postponed to the next day without consuming such beverages. Participants will first have their information recorded on the general evaluation form. Their resting heart rate variability, blood pressure, heart rate and respiratory function will then be measured. After these initial measurements at rest, the participants will be given a 20 meter shuttle run test. At the end of the test, the participant will be taken to the first assessment room for a second assessment. Here, ECG, blood pressure and heart rate, spirometer measurements will be repeated. All outcome measurements will be recorded on the evaluation form.
Receives: Other: 20 meter shuttle run test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FVC

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  2. FEV1

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  3. FEV1/FVC

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  4. FEF25

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  5. FEF75

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  6. FEF2575

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  7. PEF

    A portable spirometer device will be used for the measurement of pulmonary function. During the test, the child will be placed in an upright sitting position with the pelvis in the most neutral position. Before the test, the child will be trained, demonstrated and explained what to do during the test. A different mouthpiece will be used for each child. The nose will be closed with the help of a clothespin and the measurement will be repeated 3 times and the best result will be taken into consideration. During the test, first inhale and exhale into the spirometer mouthpiece at normal tidal volume. Then a deep breath is taken and a rapid deep exhalation is requested. The exhalation period should last at least 6 s without interruption.

    Measured: 1 hours

  8. SDNN (msn)

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  9. RMSSD (msn)

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  10. pNN50 (%)

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  11. TP (msn²)

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  12. LF (msn²), %LF, LFnorm

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  13. HF (msn²), %HF, HFnorm

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  14. LF/HF (msn²)

    HRV obtained by electrocardiography (ECG) recording is a method that provides information about sympatho-vagal balance, calculated on the basis of the variability of the intervals between heart beats. Recordings will be taken in a quiet and calm room in the supine position. A 3-way bipolar limb lead with remote bluetooth connection (poly-spectrum-8/ex) will be used for ECG recording. Electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects (coins, belts, watches, bracelets, phones, etc.) that may interfere with the ECG. Participants will be pre-informed not to move, talk, breathe normally and remain in a supine position during the recording. After 5 minutes of ECG recordings are taken, data on HRV parameters will be obtained with device-specific software.

    Measured: 1 hours

  15. Systolic blood pressure

    Care will be taken to ensure that the person being measured is not cold, not in pain, not anxious, and not urinating or having a large bowel movement before the measurement. After the brachial artery is felt by hand, the cuff will be placed 2-3 cm above the antecubital fossa so that it is not too loose or tight. Care will be taken to ensure that the skin is not pinched, the palms are open and facing upwards. They will be warned not to make a fist. The cuff will be placed in the middle of the arm at the level of the heart so that the arm and heart are in the same horizontal plane. Blood pressure measurement is started with an automatic measuring device (F.Bosch, Germany). The device inflates the cuff enough to stop arterial blood flow. As the cuff deflates, it measures oscillations in the blood flow and then calculates the blood pressure using device-specific algorithms. The device also provides the heart rate in beats per minute.

    Measured: 1 hours

  16. Diastolic blood pressure

    Care will be taken to ensure that the person being measured is not cold, not in pain, not anxious, and not urinating or having a large bowel movement before the measurement. After the brachial artery is felt by hand, the cuff will be placed 2-3 cm above the antecubital fossa so that it is not too loose or tight. Care will be taken to ensure that the skin is not pinched, the palms are open and facing upwards. They will be warned not to make a fist. The cuff will be placed in the middle of the arm at the level of the heart so that the arm and heart are in the same horizontal plane. Blood pressure measurement is started with an automatic measuring device (F.Bosch, Germany). The device inflates the cuff enough to stop arterial blood flow. As the cuff deflates, it measures oscillations in the blood flow and then calculates the blood pressure using device-specific algorithms. The device also provides the heart rate in beats per minute.

    Measured: 1 hours

  17. Heart rate per minute

    Care will be taken to ensure that the person being measured is not cold, not in pain, not anxious, and not urinating or having a large bowel movement before the measurement. After the brachial artery is felt by hand, the cuff will be placed 2-3 cm above the antecubital fossa so that it is not too loose or tight. Care will be taken to ensure that the skin is not pinched, the palms are open and facing upwards. They will be warned not to make a fist. The cuff will be placed in the middle of the arm at the level of the heart so that the arm and heart are in the same horizontal plane. Blood pressure measurement is started with an automatic measuring device (F.Bosch, Germany). The device inflates the cuff enough to stop arterial blood flow. As the cuff deflates, it measures oscillations in the blood flow and then calculates the blood pressure using device-specific algorithms. The device also provides the heart rate in beats per minute.

    Measured: 1 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start20 Sep 2024
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549192
Sponsor's protocol ID
2024/05-47
Status last verified
Jul 2025
First submitted
4 Aug 2024
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 20 meter shuttle run test in people with Heart Rate Variability and Sport, run by Inonu University at 1 site in Turkey (Türkiye).

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 1 inclusion and 1 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 17 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 Turkey (Türkiye). 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?

FVC (time frame: 1 hours). The study lists 17 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 17 Jul 2025.

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