- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07773519
Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players
2026년 8월 19일 업데이트: Shimal Hamza Hamad, Soran University
Temporal Dynamics of Biochemical and Hormonal Responses to Interval Training in Elite Female Futsal Players: A 10-Week Longitudinal Analysis Across Menstrual Cycle Phases
This study aims to investigate the biochemical, hormonal, and physiological adaptations to a 10-week periodized high-intensity interval training (HIIT) programme in elite female futsal players.
The study will examine changes in aerobic fitness, blood lactate kinetics, muscle damage biomarkers, inflammatory markers, and reproductive hormones throughout the intervention.
In addition, the influence of menstrual cycle phases on these physiological responses will be evaluated to improve understanding of sex-specific training adaptations and recovery.
The findings are expected to contribute to evidence-based, individualized training and recovery strategies for female futsal athletes.
연구 개요
상태
완전한
상세 설명
Female futsal is a high-intensity intermittent team sport requiring substantial aerobic and anaerobic fitness.
Despite increasing participation of women in competitive sports, limited evidence exists regarding the biochemical and hormonal adaptations to structured interval training, particularly across different menstrual cycle phases.
This prospective longitudinal study will recruit 32 elite female futsal players who will participate in a supervised 10-week periodized HIIT programme consisting of lactate threshold training, anaerobic intensification, and sport-specific interval training.
Physiological assessments will include VO₂max, lactate threshold, blood lactate kinetics, creatine kinase, interleukin-6, C-reactive protein, cortisol, and reproductive hormones.
Menstrual cycle phases will be monitored using validated menstrual tracking methods and hormonal confirmation.
Outcomes will be assessed repeatedly throughout the intervention to determine temporal adaptations and the influence of menstrual cycle phase on training responses and recovery.
The results are expected to support individualized, evidence-based training prescription for female athletes.
연구 유형
중재적
등록 (실제)
32
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Erbil Governorate
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Soran, Erbil Governorate, 이라크, 44008
- Soran Univeristy
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Female futsal players aged 18-30 years.
- Regular menstrual cycles.
- Participants willing to complete all scheduled testing sessions across the study period.
- Participants able to safely participate in the prescribed physical-performance testing and training programme.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Irregular menstrual cycles or diagnosed menstrual disorders.
- Use of hormonal contraceptives or hormone therapy within the past 6 months.
- Current musculoskeletal injury or any medical condition affecting physical performance.
- Use of medications known to influence menstrual function, hormonal responses, or physical performance.
- Use of performance-enhancing drugs or medications known to influence hormonal or biochemical responses.
- History of endocrine, cardiovascular, or metabolic disorders.
- Failure to complete all scheduled testing sessions.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Female Futsal Players
Female futsal players will undergo repeated standardized performance testing during different phases of the menstrual cycle.
Assessments include agility, sprint speed, repeated sprint ability, explosive power, balance, and aerobic fitness.
All participants receive the same testing protocol, and no therapeutic intervention is administered.
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Female futsal players will undergo standardized physical performance testing during different phases of the menstrual cycle.
Assessments include agility, sprint speed, repeated sprint ability, explosive power, balance, and aerobic fitness.
The study involves repeated performance assessments only, and no drug, device, surgical procedure, or therapeutic intervention will be administered.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)
기간: Baseline and Week 10
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Maximum oxygen uptake (VO₂max) measured during a graded incremental treadmill exercise test with respiratory gas analysis.
Unit of Measure: mL·kg-¹·min-¹.
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Baseline and Week 10
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Mean Change from Baseline in Velocity at VO₂max (vVO₂max)
기간: Baseline and Week 10
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Velocity at VO₂max (vVO₂max) measured during a graded incremental treadmill exercise test.
Unit of Measure: km/h.
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Baseline and Week 10
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Mean Change from Baseline in Lactate Threshold Velocity
기간: Baseline and Week 10
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Lactate threshold velocity determined during incremental exercise testing.
Lactate threshold velocity is defined as the running velocity corresponding to the lactate threshold.
Unit of measure: km/h.
Higher values indicate improved aerobic endurance.
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Baseline and Week 10
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Mean Change from Baseline in Resting Blood Lactate Concentration
기간: Baseline and Week 10
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Resting blood lactate concentration measured from venous blood samples collected under standardized resting conditions before exercise.
Unit of Measure: mmol/L.
Lower concentrations indicate improved metabolic efficiency.
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Baseline and Week 10
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Mean Change from Baseline in Lactate Clearance Rate
기간: Baseline and Week 10
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Lactate clearance rate calculated as the rate of decline in blood lactate concentration from serial post-exercise measurements obtained during standardized recovery.
The calculated clearance rate is reported as one value in mmol/L/min.
Higher clearance rates indicate improved metabolic recovery.
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Baseline and Week 10
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
기간: Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
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Serum creatine kinase concentration measured at baseline and predefined post-exercise recovery time points.
Repeated CK concentrations are evaluated across the predefined sampling time points.
Unit of Measure: U/L.
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Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
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Interleukin-6 (IL-6)
기간: Baseline; immediately post-exercise; and recovery period
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Serum interleukin-6 concentration measured as an indicator of exercise-induced inflammatory response.
Unit of Measure: pg/mL.
Lower resting concentrations and appropriate acute exercise responses indicate improved inflammatory regulation.
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Baseline; immediately post-exercise; and recovery period
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Serum Cortisol
기간: Baseline; menstrual phase-specific assessments; and Week 10
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Serum cortisol concentration measured to evaluate physiological stress responses associated with high-intensity interval training.
Unit of Measure: µg/dL.
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Baseline; menstrual phase-specific assessments; and Week 10
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Serum Estradiol
기간: Phase-specific assessments during the intervention
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Serum estradiol concentration measured to characterize hormonal status during different phases of the menstrual cycle.
Unit of Measure: pg/mL.
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Phase-specific assessments during the intervention
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Serum Progesterone
기간: Phase-specific assessments during the intervention
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Serum progesterone concentration measured to confirm menstrual cycle phase and evaluate hormonal responses during the intervention.
Unit of Measure: ng/mL.
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Phase-specific assessments during the intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Creatine Kinase (CK) Recovery Half-Life
기간: Immediately post-exercise through 72 hours
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Time required for serum creatine kinase concentration to decrease by 50% during the post-exercise recovery period.
Unit of Measure: hours.
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Immediately post-exercise through 72 hours
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Area Under the Concentration-Time Curve of Serum Creatine Kinase (CK)
기간: Immediately post-exercise through 72 hours
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Area under the serum creatine kinase concentration-time curve calculated from serum CK concentrations measured during the post-exercise recovery period.
Unit of Measure: U/L·h.
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Immediately post-exercise through 72 hours
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.
- Laursen PB, Jenkins DG. The scientific basis for high-intensity interval training: optimising training programmes and maximising performance in highly trained endurance athletes. Sports Med. 2002;32(1):53-73. doi: 10.2165/00007256-200232010-00003.
- Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
- Janse DE Jonge X, Thompson B, Han A. Methodological Recommendations for Menstrual Cycle Research in Sports and Exercise. Med Sci Sports Exerc. 2019 Dec;51(12):2610-2617. doi: 10.1249/MSS.0000000000002073.
- Constantini NW, Dubnov G, Lebrun CM. The menstrual cycle and sport performance. Clin Sports Med. 2005 Apr;24(2):e51-82, xiii-xiv. doi: 10.1016/j.csm.2005.01.003.
- Souglis A, Bourdas DI, Gioldasis A, Ispirlidis I, Philippou A, Zacharakis E, Apostolidis A, Efthymiou G, Travlos AK. Time Course of Performance Indexes, Oxidative Stress, Inflammation, and Muscle Damage Markers after a Female Futsal Match. Sports (Basel). 2023 Jun 29;11(7):127. doi: 10.3390/sports11070127.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 2일
기본 완료 (실제)
2026년 7월 1일
연구 완료 (실제)
2026년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 31일
QC 기준을 충족하는 최초 제출
2026년 8월 14일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 19일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SORANU-HIIT-2026-001
- Ethics Approval Number (기타 식별자: Soran University Institutional Review Board)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
A decision regarding sharing de-identified individual participant data collected in this study has not yet been finalized.
If data sharing is approved, only de-identified data may be considered for sharing after study completion, subject to institutional policies, ethical requirements, participant confidentiality, and applicable data-protection requirements.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .