- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07823335
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol (AERAE)
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This interventional study is designed to compare the acute endocrine responses elicited by aerobic and anaerobic exercise in sedentary women. A total of 30 healthy sedentary women aged 18-25 years will voluntarily participate. Individuals who have engaged in regular exercise or sports training, experienced a serious upper- or lower-extremity injury during the previous six months, or had a neurological, auditory, visual, or vestibular disorder during the previous year will not be included. Before participation, all individuals will be informed about the study procedures, provide written informed consent, and undergo medical screening.
Each participant will complete aerobic and anaerobic exercise protocols in separate testing sessions. The aerobic exercise protocol will consist of a progressive 20-meter shuttle run test. Participants will run continuously between two lines positioned 20 meters apart, following prerecorded audio signals. Running speed will progressively increase as the interval between signals decreases. The test will end when a participant fails to reach the designated line before the signal on two consecutive occasions.
The anaerobic exercise protocol will consist of a 30-second Wingate test performed on a Monark cycle ergometer connected to computerized analysis software. Following an unloaded acceleration period of approximately 3-4 seconds, an external resistance equivalent to 65 g/kg of body mass will be applied. Participants will be instructed to pedal against this resistance at maximal effort for 30 seconds.
Four venous blood samples will be collected from each participant: immediately before and after the aerobic exercise protocol and immediately before and after the anaerobic exercise protocol. Each sample will consist of approximately 8 mL of blood collected from an antecubital vein by qualified healthcare professionals under medical supervision. The samples will be centrifuged at 3,500 revolutions per minute to separate serum and plasma. Serum thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), and cortisol concentrations will be measured using chemiluminescence-based laboratory methods.
Exercise testing will be conducted at the Hasan Doğan School of Physical Education and Sports Laboratory at Karabuk University. Laboratory analyses will be performed at the Public Health Laboratory of the Karabuk Provincial Health Directorate. Pre-to-post-exercise changes in hormone concentrations will be evaluated within each exercise condition and compared between the aerobic and anaerobic exercise protocols.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Özgür EKEN, PhD
- Номер телефона: +905532132795
- Электронная почта: ozgur.eken@inonu.edu.tr
Места учебы
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Karabük Province
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Karabük, Karabük Province, Турция (Туркие), 78050
- Рекрутинг
- Karabuk University, Hasan Dogan Faculty of Sport Sciences
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Контакт:
- Musa ŞAHİN, PhD
- Номер телефона: +905549755058
- Электронная почта: musasahin@karabuk.edu.tr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Female participants aged 18-25 years
- Studying at the Faculty of Sports Sciences of Yalova University
- Not actively participating in regular exercise or sports training
- Voluntarily agreeing to participate in the study
- Providing written informed consent
- Being medically eligible to perform the exercise protocols following preparticipation medical screening
Exclusion Criteria:
- Having a neurological disorder during the previous year
- Having an auditory, visual, or vestibular disorder during the previous year
- Having experienced a serious upper- or lower-extremity injury during the previous six months
- Having any medical condition identified during screening that could prevent safe participation in maximal exercise testing
- Being unable or unwilling to complete either exercise protocol or blood-sampling procedures
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Aerobic and Anaerobic Exercise
Participants will complete both a progressive 20-meter shuttle run test and a 30-second Wingate anaerobic test in separate testing sessions.
Venous blood samples will be collected immediately before and after each exercise protocol to assess acute changes in serum thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), and cortisol concentrations.
Each participant will serve as her own control.
|
Participants will perform a progressive 20-meter shuttle run test by running continuously between two lines positioned 20 meters apart in time with prerecorded audio signals.
The initial running speed will progressively increase as the interval between audio signals decreases.
The test will end when the participant fails to reach the designated line before the signal on two consecutive occasions.
Participants will perform a 30-second Wingate anaerobic test on a Monark cycle ergometer connected to computerized analysis software.
Following an unloaded acceleration phase of approximately 3-4 seconds, a resistance corresponding to 65 g/kg of body mass will be applied.
Participants will be instructed to pedal against this resistance at maximal effort for 30 seconds.
Peak power, mean power, minimum power, and fatigue index will be recorded.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Change in Serum Cortisol Concentration
Временное ограничение: Immediately before and immediately after each exercise protocol
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Immediately before and immediately after each exercise protocol
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Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KBU-THYROID-2026-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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