- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07823335
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol (AERAE)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Özgür EKEN, PhD
- 전화번호: +905532132795
- 이메일: ozgur.eken@inonu.edu.tr
연구 장소
-
-
Karabük Province
-
Karabük, Karabük Province, 터키 (Türkiye), 78050
- 모병
- Karabuk University, Hasan Dogan Faculty of Sport Sciences
-
연락하다:
- Musa ŞAHİN, PhD
- 전화번호: +905549755058
- 이메일: musasahin@karabuk.edu.tr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in Serum Cortisol Concentration
기간: Immediately before and immediately after each exercise protocol
|
Immediately before and immediately after each exercise protocol
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .