- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07823335
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol (AERAE)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Özgür EKEN, PhD
- Número de teléfono: +905532132795
- Correo electrónico: ozgur.eken@inonu.edu.tr
Ubicaciones de estudio
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Karabük Province
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Karabük, Karabük Province, Turquía (Türkiye), 78050
- Reclutamiento
- Karabuk University, Hasan Dogan Faculty of Sport Sciences
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Contacto:
- Musa ŞAHİN, PhD
- Número de teléfono: +905549755058
- Correo electrónico: musasahin@karabuk.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in Serum Cortisol Concentration
Periodo de tiempo: Immediately before and immediately after each exercise protocol
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Immediately before and immediately after each exercise protocol
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KBU-THYROID-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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