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临床试验/NCT06549192
NCT06549192已完成不适用

Autonomic Responses of Amateur Child Athletes to Aerobic Exercise Test

Inonu University2 个研究点 分布在 2 个国家目标入组 53 人开始时间: 2024年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Diastolic blood pressure

研究概览

简要总结

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?

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Diastolic blood pressure

时间窗: 1 hours

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.

FEF2575

时间窗: 1 hours

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.

LF (msn²), %LF, LFnorm

时间窗: 1 hours

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.

LF/HF (msn²)

时间窗: 1 hours

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.

FEF25

时间窗: 1 hours

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.

FEF75

时间窗: 1 hours

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.

RMSSD (msn)

时间窗: 1 hours

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.

pNN50 (%)

时间窗: 1 hours

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.

FVC

时间窗: 1 hours

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.

FEV1

时间窗: 1 hours

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.

TP (msn²)

时间窗: 1 hours

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.

FEV1/FVC

时间窗: 1 hours

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.

PEF

时间窗: 1 hours

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.

SDNN (msn)

时间窗: 1 hours

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.

HF (msn²), %HF, HFnorm

时间窗: 1 hours

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.

Systolic blood pressure

时间窗: 1 hours

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.

Heart rate per minute

时间窗: 1 hours

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Nacar

Research Assistant

Inonu University

研究点 (2)

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