- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07823335
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol (AERAE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Özgür EKEN, PhD
- Phone Number: +905532132795
- Email: ozgur.eken@inonu.edu.tr
Study Locations
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Karabük Province
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Karabük, Karabük Province, Turkey (Türkiye), 78050
- Recruiting
- Karabuk University, Hasan Dogan Faculty of Sport Sciences
-
Contact:
- Musa ŞAHİN, PhD
- Phone Number: +905549755058
- Email: musasahin@karabuk.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Serum Cortisol Concentration
Time Frame: Immediately before and immediately after each exercise protocol
|
Immediately before and immediately after each exercise protocol
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBU-THYROID-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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